Job Description (JD) Deputy General Manager (DGM) Regulatory Affairs (Active Medical Devices & CE Certification)
Position Title - Deputy General Manager (DGM) Regulatory Affairs
Department: Regulatory Affairs
Reporting To: COO
Location: Bhiwadi
Purpose of the Role
To lead and manage global regulatory affairs activities for Active Medical Devices, ensuring compliance with EU MDR 2017/745, CE Marking requirements, ISO 13485, CDSCO, and other international regulatory frameworks. The role will drive regulatory strategy, product registrations, technical documentation, notified body interactions, and lifecycle compliance for existing and recent products.

Key Responsibilities
Regulatory Strategy & Compliance
Develop and implement regulatory strategies for active medical devices across EU, UK, India, and other international markets.
Ensure compliance with EU MDR 2017/745, CE Marking requirements, ISO 13485, ISO 14971, and applicable harmonized standards.
Monitor global regulatory changes and assess their impact on product portfolios.




Provide regulatory guidance during product development and design changes.
CE Certification & EU MDR Management
Lead CE Marking projects from classification through certification and post-market compliance.
Prepare, review, and maintain Technical Documentation, Design Dossiers, Clinical Evaluation Reports (CER), Risk Management Files, and PMS documentation.
Coordinate with Notified Bodies for conformity assessments, audits, and certification activities.
Support EUDAMED registrations and regulatory submissions.

Regulatory Submissions & Registrations
Oversee preparation and submission of regulatory dossiers for CE, CDSCO, UKCA, and other market registrations.
Manage renewals, amendments, change notifications, and product lifecycle regulatory activities.
Ensure timely approvals and maintenance of product licenses and certifications.
Technical Documentation & Risk Management
Review and approve Technical Files, Device Master Records, Design History F

📌 Regulatory Affairs Specialist (Bhiwadi)
🏢 Allied Medical
📍 Bhiwadi