Senior Quality
Vor 3 Tagen
Senior Quality & Regulatory Affairs Leader – Help Shape the Future of Skin Cancer Treatment
Are you driven to make a real difference in patient care? We’re partnering with a pioneering MedTech 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.
Why You’ll Love This Role:
- Transformative Impact: Shape regulatory pathways in Europe, Australia, South Africa, and the U.S., playing a vital role in making innovative treatments accessible globally.
- Leadership Opportunity: Lead, mentor, and build a high-impact team while setting the company up for regulatory success in emerging markets.
- Growth Potential: Join an ambitious, agile team at a rapidly scaling business with immense growth opportunities.
What You’ll Do:
- Develop and lead Quality System strategies to maintain and exceed regulatory compliance.
- Mentor and guide junior team members, fostering a collaborative and growth-focused environment.
- Direct end-to-end regulatory submissions for market approvals, including major new markets.
- Act as the primary contact for regulatory bodies in Europe, the U.S., and other key regions.
- Prepare and empower teams for regulatory audits, driving ongoing improvement and readiness.
- Oversee and coordinate external resources, including consultants and regulatory advisors.
- 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.
Sounds like a fit? Click apply.
Please note, only candidates with the required experience will be considered.
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