- Location
- Lucknow, Uttar Pradesh, India
- Job type
- Full-time
Required skills
- biotechnology
- compliance
- cross-functional
About the role
Q-LineBiotech Private Limited
Website:
qlinebiotech.com
Job details:
Key Responsibilities1. Regulatory Strategy & Compliance- Develop and implement regulatory strategies for product approvals in India and global markets.
- Ensure compliance with:
- Medical Device Rules, 2017 (India)
- ISO 13485:2016
- EU MDR/IVDR (2017/745, 2017/746)
- US FDA (21 CFR Part 820)
- Interpret regulatory requirements and provide guidance to cross-functional teams.
2. Product Registration & Submissions- Prepare and submit regulatory dossiers (e.g., MD-3, MD-5, MD-7, MD-12, MD-13).
- Conduct EU MDR assessments and prepare Technical Files.
- Handle product registration for IVD reagents/kits with CDSCO and other regulatory bodies.
- Compile technical documentation, including:
- Device Master File (DMF)
- Plant Master File (PMF)
- Performance Evaluation Reports
- Risk Management Files (ISO 14971)
3. Liaison with Regulatory Authorities- Act as a point of contact with regulatory authorities (e.g., CDSCO, Notified Bodies).
- Respond to queries, deficiency letters, and audit observations.
- Coordinate inspections and regulatory audits.
4. Lifecycle Management- Manage post-approval changes, variations, and renewals.
- Ensure timely submission of updates and change notifications.
- Maintain product licenses and approvals.
5. Documentation & Compliance Control- Review and approve labeling, IFU (Instructions for Use), and packaging compliance.
- Ensure alignment of technical documents with regulatory requirements.
- Maintain regulatory documentation and records.
6. Post-Market Surveillance (PMS) & PMCF- Establish and maintain PMS and PMCF systems.
- Review vigilance reports, complaints, and adverse event reporting.
- Coordinate Field Safety Corrective Actions (FSCA), if required.
7. Cross-functional Coordination- Work closely with:
- Quality Assurance
- R&D
- Manufacturing
- Marketing
- Provide regulatory input during product development and design changes.
8. Training & Awareness- Conduct regulatory training sessions for internal teams.
- Keep the organization updated with regulatory changes and updates.
Educational Qualification- Bachelor’s or Master’s degree in:
- Biotechnology
- Microbiology
- Biochemistry
- Life Sciences
- Pharmacy
- Regulatory Affairs certification (preferred)
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