Regulatory Affairs Lead (m/f/d)

Regulatory Affairs Lead (m/f/d)

Olympus Europa SE & Co. KG (OEKG) Chief Quality Officer

Your Responsibilities

1. Team Leadership: Manage and mentor two Regulatory Affairs Managers, promoting growth and high performance.
2. Strategic Guidance: Advise business units on EU/EMEA regulatory requirements, aligning strategies with business goals.
3. Product Compliance: Assess new product launches, ensuring regulatory compliance and offering strategic insights.
4. Third-Party Supplier Compliance: Lead compliance efforts for third-party products, collaborating with cross-functional teams.
5. Regulatory Process Oversight: Ensure compliance in the launch workflow, covering DoC, labeling, certificates, EUDAMED, and DMIDS.
6. Business Development Support: Liaise with senior management on mergers/acquisitions, shaping regulatory strategies for new products.
7. Conformity Assessment: Lead assessments for existing products, providing risk mitigation advice and ensuring regulatory compliance.
8. Regulatory Project Management: Oversee regulatory projects, promoting proactive compliance and continuous improvement.
9. Regulatory Intelligence: Monitor and analyze EU regulatory trends, sharing insights with internal teams.
10. EU Notification Support: Lead submissions to EU authorities, ensuring timely and accurate filings.
11. Marketing Materials Compliance: Review and approve marketing materials, ensuring compliance with regulatory standards and approved claims.
12. Product Change Management: Manage product changes across EMEA, ensuring compliance with updated regulatory requirements.

Your Qualification

1. Minimum of 7 years of experience in Regulatory Affairs, with demonstrated team management experience, preferably within a matrix organization.
2. Proven experience managing regulatory affairs projects and supporting global regulatory submissions (e.g., 510(k), CE Mark, and other international markets).
3. Expertise in preparing regulatory submissions to support product commercialization (e.g., 510(k), CE Mark Technical File).
4. In-depth experience with Quality Management System (QMS) processes and systems.
5. Global experience with a strong understanding of international regulatory processes and cross-functional teamwork.
6. Strong ability to manage relationships within Regulatory Affairs and collaborate with internal departments (R&D, Manufacturing, Supply Chain, Quality, etc.).
7. Excellent written and verbal communication skills in an international, cross-functional environment.
8. Strong IT skills with experience in regulatory systems (e.g., RIM, PLM) and Microsoft Office.

Your Competencies

We are seeking an experienced leader to manage two EU Regulatory Affairs Managers based in Hamburg. The ideal candidate will provide strategic leadership and expert guidance, ensuring regulatory compliance across the EU, EFTA, and Europe, while aligning regulatory strategies with business objectives.

The interview will be competence-based and the following competencies will be assessed:

• Build for the Future
• Deliver Results
• Lead People
• Lead Self
• Model and champion Our Core Values

Your Benefits

1. Flexible working hours, remote work possible (up to 60%).
2. 30 days of holidays per year.
3. Modern office and an inspiring working environment.
4. Employee restaurant with live cooking and healthy food (subsidized).
5. Public transport ticket (100% subsidized) or free parking space.
6. Company sport groups and an in-house company gym.
7. Employee Assistance Program to support your health, mental and emotional well-being.
8. A comprehensive company pension scheme.
9. Company medical officer and vaccination offers.
10. Childcare through our ‘Buttje&Deern’ partner.
11. Bike leasing.

About Olympus

At Olympus, we are committed to our purpose of making people’s lives healthier, safer, and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis, and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

For more information, visit www.olympus-europa.com and follow our LinkedIn account: linkedin.com/company/OlympusMedEMEA.