Roles and Responsibilities
Regulatory Affairs – Technical submissions
- Define,develop and execute regulatory strategies to ensure fast Time to market all new/existing products.
- Develop and maintain Technical Files/Design Dossier to comply with European MDD and maintain CE mark approval.
- Develop and Maintain Technical Files/Design Dossier to comply with compliances and standards (CDSCO, 510K)
- Overseeing and Planning, Compilation, review and submission of Documents as per Country Specific regulatory guideline in medical device manufacturing and coordinating with them for registration.
Regulatory Strategy Ownership
- Define regulatory pathways for new markets and customers.
- Regulatory risk assessment during customer onboarding
- Support regulatory strategy for business expansion across organization
Customer Interface
- Direct engagement with customers for regulatory strategy discussions and submission support.
Lifecycle Management
- Renewal management of any audit (surveillance, regulatory certifications , External audits from notified bodies or any customer audits
- The readiness and attentiveness regarding certifications and audits
Technical Documentation Responsibilities
- Design History File (DHF).
- Device Master Record (DMR) familiarity.- recheck
- CDSCO
- TCF
2. Regulatory Affairs & Global Compliance
Manage registrations and lifecycle maintenance for:
o EU (CE Marking – MDR 2017/745)
o ISO 13485 : 2016
o US FDA
o UK MHRA
o Health Canada
3. Audit & Compliance Management
- Regulatory audit readiness support
- Regulatory inspection coordination Lead and manage external audits (ISO, regulatory authorities, customers)
Cross-Functional Leadership & Coordination
- Coordinate with Production, QC, R&D, Supply Chain, and Materials departments
- Ensure manufacturing and QC processes comply with ISO and GMP
Required Qualifications
- Bachelor’s degree in Engineering, Biomedical, Pharmacy, Life Sciences, or related field
- Medical Device, Pharma or combination product regulatory exposure.
- Global regulated environments supporting MDR/FDA submission
- Minimum 12-16 years of total Regulatory Affairs experience.
- Strong exposure to EU MDR and global submissions mandatory
Required Certifications
Mandatory / Highly Preferred
- ISO 13485:2016 Certified Lead
- ISO 14971 Risk Management Training
- EU MDR 2017/745 & 746 Training
- CDSCO
- US FDA 510k
- Health Canada
- UK MHRA
Global submission
Preferred / Added Advantage
- RAC (Regulatory Affairs Certification – US / EU)
- MDSAP Auditor / Implementation Training
- FDA QSR (21 CFR Part 820) Training
- Clinical Evaluation & CER Writing (MDR / MEDDEV)
- Post-Market Surveillance & Vigilance Training