Head – Regulatory Affairs | Medical Device Manufacturing

Job Title: Head – Regulatory Affairs

Industry: Medical Devices / Medical Device Manufacturing

Department: Regulatory Affairs

Experience: 12–18+ Years

Location: Mohali(PB)

Employment Type: Full-time

Job Summary

We are looking for an experienced Head – Regulatory Affairs to lead regulatory strategy, product registrations, submissions, compliance, and regulatory lifecycle management for our medical device business.

The ideal candidate should have strong experience in medical device regulations, regulatory submissions, product registrations, regulatory authority interactions, and global market approvals.

Key Responsibilities

· Lead the overall Regulatory Affairs function and develop regulatory strategies aligned with business and product development objectives.

· Manage regulatory submissions, registrations, approvals, renewals, amendments, and variations for medical devices.

· Ensure compliance with applicable regulations including CDSCO/MDR 2017, US FDA, EU MDR, UK, TGA and other international markets.

· Provide regulatory guidance for new product development, product classification, intended use, claims, labeling, IFU, packaging, and product changes.

· Review and approve regulatory documentation, technical files/dossiers, clinical and performance documentation, risk management documents, and labeling.

· Lead responses to regulatory authority queries, deficiencies, observations, and requests for additional information.

· Manage regulatory requirements related to product lifecycle changes, manufacturing changes, supplier changes, design changes, and process changes.

· Lead regulatory interactions with CDSCO, FDA, Notified Bodies, Certification Bodies, and other regulatory authorities.

· Support regulatory inspections, audits, and assessment of regulatory findings and corrective actions.

· Provide regulatory input into clinical evaluation, PMS, vigilance, complaint handling, CAPA, recalls, and field safety corrective actions.

· Monitor changes in regulations, standards, and regulatory guidance and assess their impact on the organization.

· Collaborate closely with R&D, QA, QC, Manufacturing, Engineering, Clinical, Supply Chain, Product Management, and Business Development teams.

· Build, mentor, and manage the Regulatory Affairs team.

Candidate Profile

• Bachelor's/ Biomedical Engineering/Electronic & communication, Regulatory Affairs, or a related discipline.
• 12–18+ years of experience in Regulatory Affairs within the medical device industry.
• Strong knowledge of CDSCO / Medical Devices Rules, US FDA, EU MDR, and international regulatory requirements.
• Proven experience in medical device registration, regulatory submissions, technical documentation, and product lifecycle management.
• Experience dealing with regulatory authorities and notified bodies.
• Strong understanding of ISO 13485, risk management, clinical evaluation, PMS/vigilance, and applicable medical device standards.
• Excellent communication, technical writing, analytical, and stakeholder-management skills.
• Strong leadership and team-management capabilities.
• Experience with Class II/III or higher-risk medical devices will be an advantage.

Key Skills

Medical Devices | Regulatory Affairs | CDSCO | US FDA | EU MDR | Medical Device Registration | Regulatory Submissions | Technical File | Product Registration | ISO 13485 | Risk Management | Clinical Evaluation | PMS | Vigilance | Regulatory Compliance | Notified Bodies | Regulatory Strategy | Product Lifecycle Management

Interested candidates can share their updated CV along with current CTC, expected CTC, notice period, and current location.

Pay: ₹1,000,000.00 - ₹1,200,000.00 per year

Benefits

• Health insurance
• Leave encashment
• Paid sick time
• Paid time off
• Provident Fund

Work Location: In person