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.
Key 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.
* Auditor qualification desirable.
* 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.