Regulatory Affairs Manager

Overview

Are you ready to shape the future of Class III medical devices on a global scale? We’re seeking an experienced Regulatory Affairs Manager to join a global medical device company, driving compliance and innovation for life-changing Class III products. RAPS member.

Responsibilities

• Lead and maintain international product registrations, ensuring ongoing compliance.
• Prepare, evaluate, and update technical documentation; perform gap analyses against national and international regulations and standards.
• Review and monitor instructions for use and labelling in line with applicable directives.
• Collaborate closely with cross-functional teams (R&D, QA, production), customers, and regulatory authorities.
• Develop and deliver training on legal updates and regulatory requirements.
• Oversee regulatory submissions for MDR and international markets.
• Act as the main contact for regulatory matters with internal stakeholders and external partners.
• Support the regulatory team during audits.

Your Profile

• Degree in a relevant scientific or medical technology field.
• Qualification as an International Regulatory Affairs Manager (TÜV or equivalent).
• In-depth knowledge of EU and FDA regulations; proven experience with Class III submissions.
• Fluency in both German and English (essential).
• Experience or interest in international regulatory landscapes.

What’s on Offer

• A secure, rewarding position in a market-leading, growth-oriented company.
• Flat hierarchies, fast decision-making, and a culture of respectful communication.
• Flexible working hours and hybrid/home office options.
• Comprehensive training and tailored development opportunities.
• Attractive benefits, including a pension scheme, corporate discounts, a monthly voucher card, and service anniversary bonuses.

If you’re passionate about ensuring the highest regulatory standards for innovative Class III medical devices and want to work in a collaborative, forward-thinking environment, we’d love to hear from you.

To apply or learn more, feel free to reach out to Hollie Dear at Adaptive Life Science .

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