Accumax Lab Devices Pvt Ltd
Website:
accumaxlab.com
Job details:
Job Description
Position Summary
We are seeking an experienced Manager / Senior Manager – Regulatory Affairs & Compliance to lead global regulatory strategy, product registrations, and regulatory lifecycle management for Class A, B, C, and D medical devices and Prefilled Syringes (PFS).
The candidate will be responsible for end-to-end regulatory submissions, CE marking, technical documentation management, regulatory approvals, notified body interactions, and global compliance oversight.
The role requires strong experience in EU MDR, FDA regulations, ISO 13485, device registration, regulatory intelligence, and cross-functional collaboration.
Key Responsibilities
1. Global Regulatory Strategy & Product Registration
• Develop and implement global regulatory strategies for medical devices and drug-device combination products.
• Manage end-to-end product registrations and regulatory submissions across global markets.
• Handle regulatory approvals for Class A, B, C, and D medical devices.
• Lead product registrations in key markets including:
o European Union (EU MDR / CE Marking)
o US FDA
o UK MHRA
o Health Canada
o Australia TGA
o Middle East (SFDA, MOH)
o ASEAN markets
o LATAM markets
o India CDSCO
• Manage product license renewals, variations, amendments, and regulatory lifecycle activities.
2. End-to-End Regulatory Project Management
• Lead regulatory projects from concept stage through commercialization and post-market compliance.
• Plan regulatory timelines aligned with product development and commercialization schedules.
• Ensure timely regulatory submissions, approvals, and regulatory documentation updates.
• Manage multiple regulatory projects simultaneously.
3. Technical Documentation & Regulatory File Management
Lead preparation, review, and maintenance of regulatory documentation including:
• Technical File (EU MDR)
• Design Dossier
• Device Master File
• Risk Management File (ISO 14971)
• Clinical Evaluation Report (CER)
• Biological Evaluation Reports
• Post Market Surveillance (PMS)
• Post Market Clinical Follow-up (PMCF)
• Usability Engineering File
• Labeling and IFU compliance
Ensure documentation complies with EU MDR 2017/745 and other applicable international regulations.
4. CE Marking & Product Certification
• Manage CE marking activities for medical devices.
• Coordinate with Notified Bodies for certification, audits, and regulatory approvals.
• Oversee product testing, validation, and certification activities.
• Ensure compliance with harmonized standards and regulatory guidelines.
5. Regulatory Compliance for Prefilled Syringes (PFS) & Combination Products
• Manage regulatory compliance for Prefilled Syringes (PFS) and drug-device combination products.
• Oversee documentation related to:
o Container Closure System
o Extractables & Leachables
o Compatibility studies
o Stability studies
• Coordinate regulatory submissions for device-drug combination systems.
6. Quality Management System (QMS) Oversight
• Ensure alignment of regulatory activities with Quality Management System requirements.
• Maintain compliance with:
o ISO 13485
o ISO 14971 Risk Management
o GMP requirements
• Support internal audits, external audits, and regulatory inspections.
• Ensure regulatory compliance during design control, change control, and product lifecycle management.
7. Regulatory Intelligence & Compliance Monitoring
• Monitor global regulatory updates related to medical devices and drug-device combination products.
• Interpret regulatory requirements and assess their impact on company products and regulatory strategy.
• Maintain regulatory intelligence systems and compliance tracking mechanisms.
8. Notified Body & Regulatory Agency Management
• Act as the primary regulatory liaison with global regulatory authorities and notified bodies.
• Manage communications regarding:
o regulatory submissions
o technical clarifications
o regulatory inspections
• Represent the company in regulatory meetings, audits, and compliance discussions.
9. Cross-Functional Collaboration
Collaborate closely with:
• R&D
• Quality Assurance
• Manufacturing / Production
• Clinical Affairs
• Supply Chain
• Marketing
Provide regulatory guidance for:
• product development
• design control
• risk assessments
• product modifications
• change control processes
10. Leadership & Team Management
• Lead and mentor the Regulatory Affairs team.
• Establish regulatory processes and best practices.
• Support senior management with regulatory strategy and business expansion plans.
Education
Bachelor’s or Master’s degree in:
• Biomedical Engineering
• Biotechnology
• Pharmacy
• Life Sciences
• Regulatory Affairs
• Chemical Engineering or related discipline
Experience
• 12 – 14+ years of experience in Regulatory Affairs in Medical Devices / Biopharma / Combination Products.
• Strong experience with Class A, B, C, D devices.
• Hands-on experience in CE marking, EU MDR, global registrations, and regulatory submissions.
• Experience working with Notified Bodies and global regulatory agencies.
Required Technical Knowledge
Strong understanding of:
• EU MDR 2017/745
• FDA medical device regulations
• ISO 13485 Quality Management System
• ISO 14971 Risk Management
• CE Marking
• Medical Device Classification (Class A/B/C/D)
• Drug-Device Combination Products
• Prefilled Syringes (PFS)
• Post Market Surveillance
• Clinical Evaluation
Key Skills
• Global Regulatory Strategy
• Medical Device Registration
• Regulatory Submissions
• Technical File Preparation
• CE Marking
• Regulatory Compliance
• Risk Management
• Regulatory Intelligence
• Project Management
Click on Apply to know more.