Regulatory Affairs Specialist

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 new 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 Files, labelling, IFUs, and declarations of conformity.
Ensure compliance with ISO 14971 risk management requirements and clinical evaluation processes.
Support verification, validation, usability engineering, and performance evaluation activities.
Audit & Quality System Support
Lead and support audits by Notified Bodies, Competent Authorities, CDSCO, and certification agencies.
Ensure regulatory alignment with the company's Quality Management System (ISO 13485).
Drive CAPA implementation arising from audits and regulatory inspections.
Stakeholder Management
Act as the primary interface with Notified Bodies, Competent Authorities, consultants, and regulatory agencies.
Collaborate closely with R&D, Quality Assurance, Manufacturing, Clinical Affairs, Marketing, and Supply Chain teams.
Provide regulatory training and awareness programs across the organization.
Educational Qualifications
Bachelor's Degree in Biomedical Engineering, Electronics, Mechanical Engineering, Medical Devices, Life Sciences, Pharmacy, or related discipline.
Master's Degree / PG Diploma in Regulatory Affairs preferred.
Certification in ISO 13485, EU MDR, Regulatory Affairs, or Quality Systems will be an added advantage.
Experience
12-18 years of experience in Regulatory Affairs for Medical Devices.
Minimum 5 years in a leadership or managerial role.
Proven experience handling Active Medical Devices and CE Certification under EU MDR.
Strong experience dealing with Notified Bodies, technical documentation, audits, and international regulatory submissions.
Technical Competencies
EU MDR 2017/745 & CE Marking
ISO 13485 Quality Management System
ISO 14971 Risk Management
Clinical Evaluation & Post Market Surveillance (PMS)
EUDAMED Registration
CDSCO Medical Device Regulations
Technical File & Design Dossier Preparation
Audit Management & CAPA
Regulatory Intelligence & Change Management
Behavioural Competencies
Strategic Thinking
Leadership & Team Management
Cross-functional Collaboration
Strong Documentation Skills
Negotiation & Influencing Skills
Analytical and Problem-Solving Ability
Effective Communication & Stakeholder Management
Key Performance Indicators (KPIs)
Timely achievement and maintenance of CE Certifications.
Successful regulatory submissions and approvals.
Zero major regulatory non-conformities.
Audit readiness and successful audit outcomes.
Compliance with global regulatory requirements.
Effective management of product lifecycle changes and registrations.
Team Size: 3-10 Regulatory Professionals
Industry: Medical Devices -Active/Electro-Medical Devices, Diagnostic Equipment, Monitoring Systems, Therapeutic Devices.