Quality Regulatory Affairs Strategist
vor 11 Stunden
Transformative Impact in Skin Cancer Treatment
We are partnering with a pioneering MedTech company dedicated to revolutionising non-melanoma skin cancer (NMSC) treatment. Their non-invasive, painless solutions are transforming the field, and they're looking for an accomplished Quality & Regulatory Affairs Leader to lead their regulatory strategy in Munich, Germany.
About Metric Bio:
Metric Bio is a rapidly scaling business with immense growth opportunities. As a Senior Quality Manager, you will have the opportunity to join a high-impact team and shape regulatory pathways in Europe, Australia, South Africa, and the U.S., playing a vital role in making innovative treatments accessible globally.
Job Description:
You will develop and lead Quality System strategies to maintain and exceed regulatory compliance, mentor and guide junior team members, and direct end-to-end regulatory submissions for market approvals. You will act as the primary contact for regulatory bodies in Europe, the U.S., and other key regions, and prepare and empower teams for regulatory audits. Your goal will be to optimise and streamline quality and regulatory processes for efficient, global compliance.
Required Qualifications:
- Degree in engineering, biomedical sciences, or a related field (Master's or MBA is highly valued)
- 4+ years of hands-on experience in quality management and regulatory affairs for medical devices
- Demonstrated success in managing submissions, technical documentation, and market approvals (including MDD/MDR, De Novo, and 510(k) processes)
- In-depth knowledge of medical device QMS (ISO 13485 / 21 CFR 820) and experience leading audits with notified bodies
- Familiarity with essential standards such as ISO 14971, ISO 60601, or ISO 62366
Benefits:
The estimated salary for this position is €80,000 - €110,000 per year, depending on experience. Additionally, you can expect a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
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