Director/VP - Regulatory Affairs

#hiring for a Leadership role in #RegulatoryAffairs with reputed organization into Hi-end Medical Devices industry.

Job Title: Director /VP (Regulatory Affairs)

Location:

Reports To:

About the Role

Regulatory

Key Responsibilities:-

Regulatory

• Develop and execute global regulatory strategies aligned with product development and commercialization goals.
• Provide regulatory input across the product lifecycle, from development through post-market activities.
• Monitor, interpret, and communicate changes in global regulatory requirements (FDA, EU MDR, ISO 13485, MDSAP).
• Act as the point of contact with regulatory bodies and support agency interactions, including Q-subs and audits.
• Ensure compliance with global regulations, labelling standards, and post-market reporting obligations.

Submissionss Approvals

• Prepare and manage regulatory submissions including

  FDA

  Q-submissions, IDEs and related.

• Support regulatory filings and approvals in the U.S., EU, and other international markets.
• Oversee clinical documentation and data integration into marketing applications.
• Ensure submission accuracy, completeness, and adherence to timelines.

Cross-functional

• Lead and collaborate with cross-functional teams including RCD, Quality, Clinical, and Marketing.
• Coordinate submission activities to ensure high-quality, on-time deliverables.
• Manage regulatory project plans, risk assessments, and progress reports.
• Provide guidance and mentorship to junior regulatory staff or project contributors.

Qualifications:-

• Bachelor's or masters degree in Life Sciences, Engineering, Regulatory Science, or related field.
• Prior experience with a regulatory agency (e.g., US FDA) preferred.
• Minimum 10+ years of experience in Regulatory Affairs, including leadership in global regulatory projects.
• In-depth knowledge of

  FDA

  regulations

  ,

  EU

  MDR/MDD

  ,

  MDSAP

  , and

  ISO 13485

  .
• Proven success with regulatory submissions for

  Class

  II

  and

  III

  medical devices

  .
• Strong project management, communication, and organizational skills.

Preferred Skills

• Experience working in a regulated medical device environment involving

  .

• Ability to interpret complex regulatory guidelines and apply them in a practical business context.
• Demonstrated leadership in global regulatory project execution.

What We Offer

• Global exposure and professional growth opportunities
• Competitive compensation and benefits
• Opportunity to work with cutting-edge medical technologies
• A collaborative, innovation-driven environment

recruit.corp12@apexservices.in