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: [email protected]

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: [email protected]

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: [email protected]

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: [email protected]

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 [email protected]