Regulatory Affairs Manager

Adaptive Business Group; Darmstadt; Hybrid; EUR 70.000 - 90.000; Vollzeit

Benefits dieser Stelle

Flexible working hours

Hybrid/home office options

Attractive benefits including pension scheme

Comprehensive training opportunities

Zusammenfassung

A global medical device company is looking for an experienced Regulatory Affairs Manager. This role involves driving compliance and innovation for Class III products, leading international registrations, and ensuring adherence to EU and FDA regulations. The ideal candidate has a degree in a relevant field and fluency in German and English. The position offers flexible working hours, hybrid options, and attractive benefits including a pension scheme and corporate discounts.

Qualifikationen

• Proven experience with Class III submissions.
• Experience or interest in international regulatory landscapes.

Aufgaben

• Lead and maintain international product registrations.
• Prepare, evaluate, and update technical documentation.
• Review and monitor instructions for use and labelling.
• Collaborate closely with cross-functional teams.
• Develop and deliver training on legal updates.

Kenntnisse

In-depth knowledge of EU and FDA regulations

Fluency in German and English

Experience with Class III submissions

Collaboration with cross-functional teams

Ausbildung

Degree in a relevant scientific or medical technology field

Qualification as an International Regulatory Affairs Manager

Jobbeschreibung

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.