Regulatory Affairs Lead – Medical Devices

Position Overview

The Regulatory Affairs Lead will be responsible for developing and executing global regulatory strategies for new and modified medical devices. This individual will serve as the primary Regulatory Affairs (RA) lead on cross-functional project teams, ensuring regulatory submissions, testing, documentation, product labeling, and approvals are completed in alignment with product launch timelines.

The role requires strong knowledge of U.S. FDA regulations, 510(k) submissions, EU regulatory requirements, international registrations, medical device standards, and regulatory change management.

Key Responsibilities

1. Regulatory Submissions

• Prepare, review, and manage global regulatory submissions for new and modified medical devices.
• Develop and review U.S. FDA 510(k) submissions.
• Prepare and maintain EU technical documentation and supporting regulatory files.
• Support regulatory colleagues in preparing submissions for international markets.
• Ensure submissions are accurate, complete, compliant, and submitted according to project timelines.
• Coordinate regulatory documentation and responses required to obtain product approvals and registrations.

2. Regulatory Strategy & Project Leadership

• Serve as the Regulatory Affairs lead on cross-functional product development teams.
• Independently develop regulatory strategies for new and modified products.
• Determine appropriate regulatory pathways, testing requirements, documentation, and submission strategies.
• Partner with Engineering, Quality, R&D, Clinical, Manufacturing, and other teams to ensure regulatory requirements are incorporated throughout the product lifecycle.
• Ensure regulatory activities support product launch timelines and market expansion goals.
• Lead regulatory-driven projects as assigned by management.

3. Global Regulatory Strategy

• Develop and execute global regulatory strategies for product launches and market expansion.
• Determine country-specific regulatory requirements for new and modified medical devices.
• Support product registrations and regulatory approvals across domestic and international markets.
• Help ensure products remain compliant throughout their lifecycle.
• Monitor changes to applicable regulations, standards, guidance documents, and country-specific requirements.

4. Regulatory Change Management

• Initiate and manage regulatory change assessments for product modifications.
• Evaluate the regulatory impact of changes involving:
  • Product design
  • Manufacturing processes
  • Components/materials
  • Labeling
  • Intended use
  • Product specifications
• Determine whether changes require regulatory submissions, notifications, or updates to existing registrations.
• Update domestic and international registrations when necessary.
• Ensure regulatory documentation remains current and compliant.

5. Regulatory Agency Interaction

• Serve as a key point of contact for regulatory authorities.
• Lead and direct communications with regulatory agencies as needed.
• Prepare responses to regulatory questions, requests for information, and deficiencies.
• Support regulatory negotiations and discussions related to product approvals and registrations.
• Maintain professional relationships with applicable regulatory authorities.

6. Audits & Compliance

• Plan, lead, and support internal and regulatory agency audits.
• Prepare regulatory documentation and teams for audit activities.
• Respond to regulatory findings and support corrective actions where necessary.
• Ensure regulatory processes remain aligned with applicable global requirements.
• Identify compliance risks and work with cross-functional teams to address them.

7. SOPs & Regulatory Procedures

• Develop, revise, and maintain company Standard Operating Procedures (SOPs) related to Regulatory Affairs.
• Ensure SOPs reflect current global regulatory requirements.
• Establish processes that support consistent regulatory compliance across the organization.
• Help improve regulatory processes and documentation practices.

8. Labeling & Product Documentation

• Review medical device product labeling to ensure compliance with applicable regulatory requirements.
• Evaluate labeling changes from a regulatory perspective.
• Ensure product claims, instructions, warnings, and other labeling content meet market-specific requirements.
• Partner with cross-functional teams to implement compliant labeling.

9. Training & Mentoring

• Provide regulatory guidance to Regulatory Affairs employees and cross-functional teams.
• Train and mentor less-experienced RA professionals.
• Educate Engineering, Quality, R&D, Manufacturing, and other teams on applicable regulatory requirements.
• Serve as a regulatory subject-matter expert within project teams.

What They're Really Looking For

The strongest candidate will likely have:

• Medical device Regulatory Affairs experience
• Hands-on experience with FDA 510(k) submissions
• Experience with EU technical documentation
• Experience with global/international regulatory submissions
• Strong understanding of medical device regulations and standards
• Experience developing regulatory strategies
• Experience serving as an RA lead on cross-functional projects
• Experience with regulatory change assessments
• Experience interacting directly with FDA and/or international regulatory agencies
• Audit experience
• Experience writing or maintaining SOPs
• Medical device labeling review experience
• Ability to interpret regulations, standards, and guidance documents
• Strong project management and communication skills

Keywords to Look for on Resumes

Regulatory Affairs | Medical Devices | FDA | 510(k) | EU MDR | Technical Documentation | Global Regulatory Strategy | International Registrations | Product Registration | Regulatory Submissions | Regulatory Agency | FDA Correspondence | Change Control | Change Assessment | Design Changes | Labeling | SOP | Audits | Regulatory Compliance | Medical Device Regulations | ISO 13485 | Risk Management | Cross-Functional Teams | Product Launch | Market Expansion

Candidate Level

I would treat this as a mid-to-senior level Regulatory Affairs position, not an entry-level RA role. The biggest differentiator is whether the candidate has actually owned or led regulatory submissions and strategies, rather than simply supporting regulatory documentation.

Top priority: Someone who has personally handled FDA 510(k) submissions + global medical device registrations + regulatory strategy/change assessments.