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RA Specialist (US-FDA)
Job Location: Chennai
CellBios Healthcare & Lifesciences Pvt. Ltd was established in 2008 in Chennai, India to serve the Biotech and Medical industries. The company is focused on scientific R&D, manufacturing, and sales to provide Cord Blood processing sets, CellStor Freezing bags, cryopreservation solutions, bone marrow transplantation products, and accessories to the market.
Role Description
This is a full-time on-site role for a Regulatory Specialist. The Regulatory Specialist will be responsible for ensuring regulatory compliance, staying up-to-date with regulatory requirements, and utilizing analytical skills to identify potential issues. The Regulatory Specialist will also be responsible for communicating with regulatory agencies and providing regulatory affairs support to other teams.
- Designation: RA Specialist (US-FDA)
- Job Department: Regulatory Affairs
- Years of Experience: Minimum 5 Years in Medical Device/ Pharma/ Life science
- Regulatory Experience: Minimum 3 years in US FDA/ MDSAP/ 510 K submission
- Industry/ Background – Medical Device /Pharma/Lifesciences Industry
- Qualification: M Sc Life Science/ BTech Medical / B Pharm/ M Pharm
- Employment Status: Permanent
- Job Location: Chennai
- Workplace Type: On-site
Minimum Requirements:
- Minimum of 2-3 years of experience in regulatory affairs Healthcare industry, with specific experience in USFDA / 510K submission and MDSAP Audit preparation.
- understanding of cGMP and US FDA guidelines.
- Ability to effectively present information to management and other groups
- Experience in preparing and managing regulatory dossiers, including DMFs, INDs, MAAs, and other regulatory submissions.
- Excellent understanding of pharmaceutical product development processes, manufacturing, and quality control.
- Strong attention to detail and accuracy in documentation and data management.
- Effective communication and interpersonal skills, with the ability to collaborate with cross-functional teams and interact with regulatory authorities.
- Proficiency in using regulatory affairs software, document management systems, and Microsoft Office Suite.
- Ability to multitask, prioritize workload, and meet tight deadlines in a fast-paced and dynamic environment.
- Knowledge of international regulatory requirements and experience with Health Canada/ Brazil/ Japan/ USFDA/ Australia regulatory submissions is a plus.
- Certification or training in USFDA/ Other Regulatory affairs is preferred
Roles and Responsibilities
- The candidate will be responsible for handling and following of Regulatory process of USFDA / 510 K Submission.
- Prepares eCTD filings for submission to the US Food and Drug Administration (US FDA) and other global regulatory agencies.
- Review and interpret regulatory guidelines and communicate updates and changes to internal stakeholders.
- Coordinate with cross-functional teams, including R&D quality assurance, and manufacturing, to gather necessary information and documentation for dossier preparation.
- Collaborate with regulatory authorities and agencies to address queries, provide additional information, and facilitate dossier review processes.
- Stay updated with evolving regulatory requirements and industry trends related to USFDA.
- Assist in the preparation and submission of post-approval regulatory filings, variations, and renewal applications.
- Prepares all product listing, facility registration, product label updates, and facility identification for submission to the US FDA.
- Support and coordinate for MDSAP / ISO 13485 / QMS Audits, Internal Audits, and Complaints and CAPA process.
- Responsible for verifying specification of excipients, active, finished product and packaging material, and all required documents.
Send your resume to: hr@cellbios.com
Designation: RA Specialist (EU MDR)
Job Department: Regulatory Affairs
Years of Experience: Minimum 5 Years in Medical Device/ Pharma/ Life science
Regulatory Experience: Minimum 3 years in EU MDR 2017
Industry/ Background: Medical Device /Pharma/Lifesciences Industry
Qualification: M Sc Life Science/ BTech Medical / B Pharm/ M Pharm
Employment Status: Permanent
Job Location: Chennai
Workplace Type: On-site
Minimum Requirements:
- Minimum of 2-3 years of experience in regulatory affairs Healthcare industry, with specific experience in EU MDR / cGMP dossier preparation.
- Clear understanding of cGMP and EU MDR guidelines.
- Ability to effectively present information to management and other groups
- Experience in preparing and managing regulatory dossiers, including Technical File, CER, GSPR, PMS, SOTA, Clinical Evaluation.
- Excellent understanding of Healthcare / Medical Device product development processes, manufacturing, and quality control.
- Strong attention to detail and accuracy in documentation and data management.
- Effective communication and interpersonal skills, with the ability to collaborate with cross-functional teams and interact with regulatory authorities.
- Proficiency in using regulatory affairs software, document management systems, and Microsoft Office Suite.
- Ability to multitask, prioritize workload, and meet tight deadlines in a fast-paced and dynamic environment.
- Knowledge of international regulatory requirements and experience with global regulatory submissions is a plus.
- Certification or training in EU MDR Regulatory affairs is preferred
Roles and Responsibilities
- Candidate will be responsible for handling and follow-up of Regulatory process of EU MDR Documentation and Submission.
- Prepares TD filings for submission to the EU MDR – Notified Body / regulatory agencies.
- Review and interpret regulatory guidelines and communicate updates and changes to internal stakeholders.
- Coordinate with cross-functional teams, including R&D quality assurance, and manufacturing, to gather necessary information and documentation for dossier preparation.
- Collaborate with regulatory authorities and agencies to address queries, provide additional information, and facilitate dossier review processes.
- Stay updated with evolving regulatory requirements and industry trends related to USFDA.
- Assist in the preparation and submission of post-approval regulatory filings, variations, and renewal applications.
- Prepares all product listing, facility registration, product label updates and facility identification for submission to the EU MDR Notified body.
- Support and coordinates for ISO 13485 / QMS Audits/ EU NB Audits , Internal Audits, and Complaints and CAPA process.
- Responsible for to verify specification of excipients, active, finished product and packaging material and all required documents.
Send your resume to: hr@cellbios.com
Regulatory Affairs Specialist
Designation: Regulatory Affairs Specialist
Job Department: Regulatory Affairs – Medical Device
Years of Experience: Minimum 5 Years in Medical Device/ Pharma/ Life science
Regulatory Experience: Minimum 2 years in Indian Regulatory/ ROW registration
Industry/ Background: Medical Device /Pharma/Lifesciences Industry
Qualification: M Sc Life Science/ BTech Medical / B Pharm/ M Pharm
Employment Status: Permanent
Job Location: Chennai
Workplace Type: On-site
Roles and Responsibilities
Indian & ROW Regulatory Experience:
- The candidate will be responsible for handling and follow-up of Regulatory Affairs of Indian Central /State licensing. Liaison with CDSCO, State Licensing Authority for product approval
- Compilation of Technical dossiers and preparation of applications to regulatory bodies for all necessary approvals. CDSCO, ROW, Industry Associations, Review of dossiers of Medical Device products.
- Coordination between factory and Government Authorities of Indian and ROW countries for Preparation of Post-approval submissions e. g. Variations, Renewals, Annual Reports, Amendments, etc.
- Candidates should be in a position to handle the Application, compilation, and review of regulatory documents, needed for ROW registration.
- Monitor changes in the ROW / External regulatory environment & impact assessment of the same for business. Minimize such impacts through influencing and internal planning for compliance.
Other Factory Responsibilities:
- Candidate should have good communication skills to get all required updated information from Internal Departments as well as with Government Authorities.
- Candidates should have sound knowledge of QMS Audits, CDSCO Audits, Internal Audits, Complaints, and CAPA processes.
- Responsible for verifying specification of excipients, active, finished product and packaging material, and all required documents.
- Responsible for Application, review, coordination, and follow-up of Regulatory process.
- Responsible for collecting technical documents from various departments Specifications for Raw materials and Finished products and final review before submission.
Send your resume to: hr@cellbios.com
Quality Assurance Manager (Medical Devices)
Experience: 7 – 10 Years
Education: B.E/ B.Tech in Biomedical Engineering / Biotechnology/MSc – Biotech/Ph.D.
Job Location: Chennai
Job Description: The Quality Assurance Manager will be responsible for ensuring that our products meet regulatory standards and customer requirements. The successful candidate should have a strong background in quality assurance within the medical device industry, along with expertise in ISO 13485, Indian MDR, CE, US FDA, EU MDR, and MDSAP regulations. They should also possess excellent documentation and validation knowledge to ensure compliance with regulatory standards.
Roles and Responsibilities:
- Develop and implement quality assurance strategies and processes to ensure compliance with CE, US FDA, and EU MDR regulations.
- Establish and maintain quality management systems to support product development, manufacturing, quality and distribution processes.
- Conduct audits and inspections to ensure adherence to regulatory requirements and medical quality standards.
- Provide guidance and training to employees regarding quality assurance procedures, regulations, and documentation requirements.
- Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality is built into product development and manufacturing processes.
- Lead risk management activities and ensure appropriate mitigation measures are in place.
- Oversee the validation of manufacturing and sterilization processes.
- Manage the documentation process, including the creation, review, and approval of quality-related documents, such as standard operating procedures (SOPs), work instructions, and validation protocols.
- Monitor and analyze quality metrics to identify trends, implement corrective actions, and drive continuous improvement.
- Serve as the primary point of contact for regulatory agencies during inspections and audits.
- Stay up to date with evolving regulations, industry standards, and best practices related to medical device quality assurance.
- Responsible for Quality Assurance Documentation and quality of the products for product release.
Qualifications and Experience:
- Bachelor’s / Master’s degree / Ph.D. in biotechnology and/or a relevant experience in the scientific field.
- 7-10 years of experience in quality assurance within the medical device industry.
- In-depth knowledge of ISO 13485, Indian MDR, CE, US FDA, and EU MDR regulations.
- Experience in Applicable Product Standards in ISO / ASTM / USP.
- Strong leadership skills with the ability to influence and collaborate across teams.
- Excellent communication and interpersonal skills.
- Detail-oriented with strong analytical and problem-solving abilities.
- Handling audits related to State FDA, CDSCO, CE Marking, US FDA 510K, MDSAP, and Notify body for QMS/ MDR.
Send your resume to: hr@cellbios.com
Quality Assurance & Regulatory for Medical Devices (Cell therapy / Bioprocess / BMT)
Job opening for Executive / Sr. Executive / Asst. Manager / Manager for Quality Assurance (QA) & Regulatory for Medical Devices
Reporting to: Head Quality and Regulatory
Education: B.E/ B. tech in biomedical engineering / Biotechnology/MSc – Chemistry /B. Pharm
Location: Chennai
The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with regulatory affairs.
Roles and Responsibilities:
- Writing Technical documents, carrying out Literature survey, review, data extraction and data analysis for new medical device products.
- Conduct Technical Review for Manufacturing and Quality Documents in compliance with Regulatory standards Good Manufacturing Practice, EU MDR Regulation 2017/745, USFDA, MDSAP and India MDR
- Creation and updating validation Protocols and Reports (Product/ Packaging Design verification & Validation and Adoption activities)
- Preparation for protocols and procedures, during development phase as well as manufacturing and post-marketing surveillance studies. Clinical evaluation studies.
- Risk assessment, benefit analysis and risk management as per ISO 14971
- To perform detailed assessment on Medical Products including Package failure analysis.
- Handling audits related to State FDA, CDSCO, CE Marking, US FDA 510K, MDSAP and Notify body for QMS/ MDR.
Experience:
- Quality assurance/ Regulatory affairs experience: 5 years exp. in writing technical documentation’ role in medical devices preferred.
- Good knowledge on Medical Devices Rules and BPSA.
- Experience with ISO13485, 21 CFR Part 820, EU MDR and other regulatory requirements associated with medical devices
- Training on ISO 13485:2016, MDR & ISO 14971 -Risk Management.
Send your resume to: hr@cellbios.com
Quality Assurance & Regulatory Affairs Executive: Cell therapy/ Bioprocess/ BMT
Reporting to: Head Quality and Regulatory
Location: Chennai
Education: B.E/ B. tech in biomedical engineering / Biotechnology/MSc – Chemistry /B. Pharm
Roles and Responsibilities:
- Writing Technical documents, carrying out Literature survey, review, data extraction and data analysis for new medical device products.
- Conduct Technical Review for Manufacturing and Quality Documents in compliance with Regulatory standards Good Manufacturing Practice, EU MDR Regulation 2017/745, MDSAP and India MDR
- Creation and updating validation Protocols and Reports (Product/ Packaging Design verification & Validation and Adoption activities)
- Preparation for protocols and procedures, during development phase as well as manufacturing and
- post-marketing surveillance studies.
- Risk assessment, benefit analysis and risk management as per ISO 14971
- To perform detailed assessment on Medical Products including Package failure analysis.
- Handling audits related to State FDA, CDSCO, CE Marking, US FDA 510K, MDSAP and Notify body for QMS/ MDR.
Experience:
- Regulatory Affairs Experience: 2 – 4 years’ experience in writing technical documentation’ role in medical devices preferred
- Good knowledge on Medical Devices Rules and BPSA.
- Experience with ISO13485, 21 CFR Part 820, EU MDR and other regulatory requirements associated with medical devices
- Training on ISO 13485:2016, MDR & ISO 14971 -Risk Management.
Send your resume to hr@cellbios.com
Quality Control Executive
Reporting to: Head – QC
Location: Chennai
Education: B.E/ B. tech in biomedical engineering / Biotechnology/MSc – Chemistry /B. Pharm
Roles:
To work in Quality Control activities of the Lab with regard to Testing of Raw Material, In process, Finished Products, documentation and quality management system requirements at Quality Control lab. To ensure that the requirements of MDR, ISO 13485, ISO 3826, USFDA QSR – CFR Part 820 and such other international standards are implemented and maintained. Handle regulatory and customer audits and customer requirements related quality and other statue.
Responsibilities:
- Ensure all phases of a manufacturing and other handling process meets the standards or requirements of the quality plan including in-process check.
- Play an active role in all stages of the production process (Raw Materials Analyst), during production itself (In Process Analyst) or at the end of manufacture (Finished Product testing).
- Timely completion of all experiments according to established Standard Operating Practices (SOPs), and also Good Laboratory Practices (GLP) or Good Clinical Practices (GCP), ISO/ EN standards for highly regulated industries.
- Basic lab-work and use of chemical/pharma/microbiology testing equipment and processes.
- Prepare technical documents that report the results of their lab work. (Batch release records, sterility data, stability data, validation data)
- Responsible for minor equipment troubleshooting, calibration and repair.
- Establish specifications for conducting assays and writing standard operating procedures.
- Follow practices/ documentation pertaining to MDR and all applicable statutory requirements
- Responsible for QMS elements viz. Change control, Deviation, CAPA etc. and its tracking for closure.
- Monitoring of supplier performance/ compliance documents (Audit response/CAPA) and support the team in taking informed decision on approving the supplier/vendor/service providers
Qualifications and Skills Necessary:
- Master’s degree or equivalent (or higher) in chemistry/ plastic engineering/ polymer science/ microbiology or Biotechnology.
- Ability to work both in a team or individually and good mathematical skills are all required.
- Proven knowledge of methods/techniques of medical devices. ISO 3826
- Experience in Medical devices QMS ISO 13485 and wet lab/ instrumentation.
- Hands on experience in EN-ISO 13485, EU MDR, CE marking, USFDA QSR – CFR Part 820 and such other international standards.
- Experience in handling audits/ inspection of Indian medical devices rule requirements.
Send your resume to hr@cellbios.com
Job Opening for Chief Financial Officer
The ideal candidate will be responsible for financial strategy, financial planning and analysis, financial reports, company audits, compliance, and bank relationships. They will collaborate with the CEO and the executive team to make decisions regarding company’s financial strategy and operations. The candidate will possess a strong background in finance and management.The CFO will play an active role in the budgeting and planning function. Formulate and evaluate all financial planning activities / processes including operating and strategic plans forecasts. Managing strong financial strategy to implement and monitor overall financial plans and accounting practices of the Company to ensure adherence to our business plans. Leading the budgeting and planning process and track performance against budgets, sales, and monitor investments and cash flows. Responsible for contracts and procurement, Internal Audit & Risk management, Liasioning Provide financial and business inputs for effective decision making and lead post implementation reviews. Control and monitor the revenue assurance function to ensure maximization of revenue.
Responsibilities
- Creating Tax Strategies to reduce obligations
- Monitoring strategic business plans
- Financial strategy development
- Manage the company’s budgeting, accounting and financial planning
- Making sure company is in compliance with all regulations
- Plan and perform risk management duties
- Plan, implement and manage investment strategies
- Prepare and present forecasting reports
- Overall handling Finance and Accounts department
- Analysis and assessment of capital required over the plan period and arranging finance
- Develop and maintain accurate and effective financial statements.
- Responsible for complete tax planning, tax compliance and monitoring other taxation issues for the company.
- MIS Reporting
Role: Head/VP/GM-CFO/Financial Controller
Industry Type: Medical Devices
Functional Area: Finance & Accounts
Qualifications
- Strong finance-based analytical skills
- 7 – 10 years’ of finance experience
- CA / MBA / PGDM in Finance
Please send your resume to hr@cellbios.com
Sales Manager – Single Use Disposables
Job Locations: Bangalore, Hyderabad, Pune
Roles and Responsibilities
- Present, promote and sell Single use disposables products/services to existing and prospective customers
- Performs market research and analysis, to understand existing market share and create a stronger name in the space
- Update management with reports on customer needs, problems, interests, competitive activities, and potential for new products and services.
- Expedite the resolution of customer problems and complaints to maximize satisfaction
- Analyze the territory/markets potential, track sales and status reports
- Maintain an updated database/MIS Report for the assigned territory sales.
- Maintaining positive business relationships to ensure future sales
- Achieve agreed upon sales targets and outcomes within schedule
- Monitors external and internal environment for development of new market segments and new products
- And ensure proper Branding & Campaigns for sales improvement.
Desired Candidate Profile
- 2-5 Years Sales experience in single use disposable products (medical devices) in India.
- Team Player ability to work as a part of team and problem-solving skills
- Excellent selling, negotiation and communication skills
- Highly motivated and target driven with a proven track record in sales
- Monitor competition and provide suggestions for improvement
- Planning and organization skills and strong analytical abilities
- Relationship management skills and openness to feedback
Education: B.Tech/B.E. in Bio-Chemistry/Bio-Technology, B.Pharma in Pharmacy, MBA
Send your resume to hr@cellbios.com
National Sales Manager (BMT & Transfusion)
Roles and Responsibilities
- Present, promote and sell Bone marrow transplant (BMT) and Transfusion products/services to existing and prospective customers
- Performs market research and analysis, to understand existing market share and create a stronger name in the space
- Update management with reports on customer needs, problems, interests, competitive activities, and potential for new products and services.
- Perform cost-benefit and needs analysis of existing/potential customers to meet their needs
- Expedite the resolution of customer problems and complaints to maximize satisfaction
- Analyze the territory/markets potential, track sales and status reports
- Maintain an updated database/MIS Report for the assigned territory.
- Maintaining positive business relationships to ensure future sales
- Achieve agreed upon sales targets and outcomes within schedule
- Monitors external and internal environment for development of new market segments and new products
- To formulate a specific budget and expenditure plan the new Business Plans
- Team Building Collaborate with Sales department to ensure proper Branding & Campaigns
- Conduct product training to sales team and manage products/brands.
Desired Candidate Profile
- Should have handled BMT and transfusion products/ services in India for five years.
- Team Player ability to work as a part of team and problem-solving skills
- Excellent selling, negotiation and communication skills
- Highly motivated and target driven with a proven track record in sales
- Monitor competition and provide suggestions for improvement
- Planning and organization skills and strong analytical abilities
- Relationship management skills and openness to feedback
Education: B.Tech/B.E. in Bio-Chemistry/Bio-Technology, B.Pharma in Pharmacy, MBA
Send your resume to hr@cellbios.com
National Sales Manager – Medical & OEM
Roles and Responsibilities
- Present, promote and sell medical devices to existing and prospective customers
- Identify and develop original equipment manufacturer (OEM) business for manufacturing.
- Performs market research and analysis, to understand existing market share and create a stronger name in the space for medical devices.
- Update management with reports on customer needs, problems, interests, competitive activities, and potential for new products and services.
- Perform cost-benefit and needs analysis of existing/potential customers to meet their needs
- Expedite the resolution of customer problems and complaints to maximize satisfaction
- Analyze the National level/markets potential, track sales and status reports
- Maintain an updated database/MIS Report for the assigned territory.
- Maintaining positive business relationships to ensure future sales
- Achieve agreed upon sales targets and outcomes within schedule
- Monitors external and internal environment for development of new market segments and new products
- To formulate a specific budget and expenditure plan the new Business Plans
- Team Building Collaborate with Sales department to ensure proper Branding & Campaigns
- Conduct product training to sales team and manage products/brands.
Desired Candidate Profile
- Should have handled Medical products and OEM services in India for five years.
- Team Player ability to work as a part of team and problem-solving skills
- Excellent selling, negotiation and communication skills
- Highly motivated and target driven with a proven track record in sales
- Monitor competition and provide suggestions for improvement
- Planning and organization skills and strong analytical abilities
- Relationship management skills and openness to feedback
Education: B.Tech/B.E. in Bio-Chemistry/Bio-Technology, B.Pharma in Pharmacy, MBA
Send your resume to hr@cellbios.com
We are hiring Digital Marketing Executives
Job Description
- Planning, execution, and optimization of online marketing strategies.
- Maintain a strong online presence for our company.
- Ability to implement online marketing strategies through social media accounts.
- Achieve superior customer engagement and intimacy, website traffic and revenue by strategically exploiting all aspects of the social media marketing roadmap.
- Develop original content and suggest creative ways to attract more customers and promote brands.
- Increase web traffic and customer engagement metrics aligned with broader marketing strategies.
- SEO Keyword planning and Content Writing for websites and Blogs.
- Creating effective Social Media Plans.
- Conducting Campaigns & Contests for various Social Media Platforms.
- Creating reports showcasing Web Analytics data and site evaluation.
Key skills
- Digital Marketing
- Social Media Marketing
- SEO
- Online Marketing
- Web Analytics
- Article Submission
- Email Campaigns
Send your resume to: marketing@cellbios.com, hr@cellbios.com
Mechanical Design Engineer (SolidWorks)
Experience: Fresh / Experience, 0 – 2 Years
Education: DME / B.E/ B.Tech in Mechanical (or) Biomedical Engineering
Job Location: Chennai (OMR, Karapakkam)
Job Description:
The primary responsibility of the selected candidates will involve drafting and designing various products using SolidWorks specifically tailored for medical device manufacturing.
Roles and Responsibilities:
- Engaging in all phases of new development, prototyping, test method design, design evaluation, design reviews, design specifications, design verification and validation, design protocols, and reports, and transfer to production activities in a timely effective manner.
- Product testing and evaluation, completion of test reports to support design selection.
- Organize projects and maintain Design History Files (DHF)
- Complete design drawings in Solid Works or a similar drafting tool and create prototypes to progress the development through its design stages
- Development of component specifications, inspection methods, bills of materials, and manufacturing processes.
- Introduction of new equipment, materials, and technologies.
- Manage and drive project tasks to ensure the timely completion of goals.
- Product performance evaluations.
- Contribute to innovation and creativity within the team through the filing of disclosures and patents.
- Hold regular goal meetings and document minutes and actions.
- Compliance with Quality, Regulatory, and company policies and systems.
Qualifications:
- Experience in SolidWorks – Solid Modelling, Surface Modelling, Assembly, Flow analysis & Simulation
- DME / BE / B.Tech. Degree in Mechanical Engineering or Biomedical Engineering
- Knowledge of DMR / DHF (Design Plan, Design input/output, Validation & Verification, and Design Transfer) would be an added advantage.
- Understanding of quality and regulatory requirements for medical devices classification
- A proven record of interpersonal skills to handle clients should be Result oriented and self-driven
Industry Type: Medical Device Manufacturing
Employment Type: Full-Time, Permanent
Experience: Fresh/Experience, 0-2 years
Send your resume to legoan@cellbios.com / hr@cellbios.com
