Regulatory Affairs Manager

elemed; Paris; Hybride; EUR 60 000 - 80 000; Temps partiel

Résumé du poste

A biopharma company in Paris is seeking a Senior Consultant for Device Regulatory Documentation & Compliance. In this role, you will mentor a team, develop regulatory documentation, and ensure compliance for medical devices and combination products. This opportunity is perfect for someone with 5–7 years of experience in the field, a thorough understanding of regulatory standards, and excellent communication skills. The position offers a supportive and collaborative environment in a fast-paced industry.

Qualifications

• 5–7 years of experience in medical devices and combination products, with a strong compliance/documentation track record.
• Deep understanding of ISO 13485, 21 CFR Part 820, 21 CFR Part 4, and EU MDR.
• Fluent English communication (written and spoken).

Responsabilités

• Lead and mentor the Regulatory Documentation & Compliance team.
• Develop and maintain essential regulatory documentation for submissions.
• Co-operate with various departments to build regulatory strategies.
• Monitor regulatory changes and advise the organization.
• Prepare Design Reviews, guiding teams with best practices.
• Support interactions with regulatory agencies for documentation.
• Define and implement systems for efficient regulatory integration.
• Key role in risk management and post-market surveillance documentation.

Connaissances

Regulatory strategy

Documentation systems

Mentoring

ISO 13485 compliance

Fluent English communication

Description du poste

Overview

Title: Senior Consultant – Device Regulatory Documentation & Compliance

Location: Paris (3 days onsite - 2 WFH)

The Company

We believe great work happens when brilliant minds come together with a shared purpose. This biopharma company is known for its dedication to employee happiness, its collaborative environment, and its passion for bringing groundbreaking combination products to market. With a culture that fosters community, learning, and innovation, this is a place where experts thrive—and where your voice will truly matter.

The Opportunity

Do you love working in collaborative environments where your leadership makes a difference?

Are you passionate about crafting regulatory strategy for cutting-edge medical devices and combination products?

Do you dream of taking ownership, mentoring teams, and shaping documentation processes that define global standards?

Are you looking for the chance to build something meaningful, in a fun and engaging setting?

This is your opportunity to step into a senior leadership role with high visibility and influence. As the Senior Consultant for Device Regulatory Documentation & Compliance, you will take the lead on critical global submissions for medical devices and combination products. You’ll be at the center of regulatory strategy, partnering with cross-functional teams to drive compliance, build documentation systems, and respond to regulatory authorities with confidence.

Responsibilities

• Lead and mentor the Regulatory Documentation & Compliance team, fostering a high-performing, collaborative culture.
• Develop and maintain essential regulatory documentation (DHF, DMR, etc.) for combination product submissions in the US and EU.
• Co-operate with Product Development, Quality Assurance, MSAT, and Regulatory Affairs to build regulatory strategies aligned with project priorities.
• Monitor regulatory changes and advise the organization on innovative ways to stay compliant.
• Prepare and lead Design Reviews, and guide internal teams with best practices.
• Support interactions with regulatory agencies and contribute documentation for INDs, IMPs, BLAs, MAAs, and more.
• Define, improve, and implement systems that make regulatory integration more efficient and traceable.
• Play a key role in risk management and post-market surveillance documentation.

Qualifications

• 5–7 years of experience in medical devices and combination products, with a strong compliance/documentation track record.
• Deep understanding of ISO 13485, 21 CFR Part 820, 21 CFR Part 4, and EU MDR.
• Fluent English communication (written and spoken).

How to apply

If you are interested in this exciting role, please send your application directly to [e-mail]

Please note: Due to the high volume of applications we sometimes receive, our team might not be able to contact each applicant individually regarding the status of their application. If you do not hear from us after 10 days, please consider your application unsuccessful.

Check out more opportunities: Visit https://www.elemed.eu/vacancies/

Position details

• Seniority level: Mid-Senior level
• Employment type: Contract
• Job function: Quality Assurance, Manufacturing, and Business Development
• Industries: Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Hospitals and Health Care

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.