Regulatory Affairs Specialist

Allied Medical Limited; Bhiwadi; On-site; INR 1,600,000 - 3,200,000; Full time

Job summary

Allied Medical Limited in Bhiwadi seeks a Deputy General Manager (DGM) Regulatory Affairs to lead global regulatory activities for Active Medical Devices. You will drive strategy, registrations, documents, and Notified Body interactions across EU, UK, and India.

The role requires 12–18 years in Regulatory Affairs for Medical Devices, with leadership experience and a track record in CE Certification under EU MDR. ISO 13485 and CDSCO familiarity are essential.

Qualifications

• Bachelor's degree in Biomedical Engineering, Electronics, Mechanical Engineering, Medical Devices, Life Sciences, Pharmacy or related.
• Master's Degree or PG Diploma in Regulatory Affairs preferred.
• Certification in ISO 13485, EU MDR, Regulatory Affairs, or Quality Systems advantageous.

Responsibilities

• Lead regulatory strategy and ensure compliance across EU, UK, India, and other markets.
• Manage CE and other market registrations, renewals, changes, and lifecycle activities.
• Coordinate with Notified Bodies for conformity assessments, audits, and certifications.
• Prepare and maintain Technical Documentation, Design Dossiers, CER, and PMS files.
• Interact with authorities and Notified Bodies; support EUDAMED registrations.

Skills

Regulatory strategy

Regulatory submissions

Audit & CAPA

Cross-functional collaboration

Team leadership

Notified Bodies liaison

Lifecycle management

Documentation excellence

Risk management

Clinical evaluation

Education

Bachelor's in Biomedical Engineering/related

Master's in Regulatory Affairs (preferred)

ISO 13485/EU MDR/Quality Systems certification (advantage)

Tools

ISO 13485

EU MDR

ISO 14971

EUDAMED

Job description

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.