Senior Regulatory Affairs Manager (m/f/d)

OLYMPUS EUROPA SE & CO. KG; Hamburg; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A global medical technology company in Hamburg seeks a Senior Regulatory Affairs Manager. This role involves managing registration cases and ensuring compliance with regulatory standards while coordinating with multiple regions. Candidates should have a diploma or master's degree and at least 5 years of regulatory affairs experience. Benefits include 30 days of annual leave, flexible working hours, and comprehensive wellness programs.

Leistungen

30 days of annual leave

Flexible work time model

Holiday and Christmas bonuses

Corporate benefits discounts

Comprehensive pension scheme

Company restaurant

Employee Assistance Program

Public transportation subsidy

Access to in-house gym

Qualifikationen

• 5+ years of experience in regulatory affairs with 10+ registration projects.
• Ability to explain complex regulatory concepts to non-regulatory stakeholders.

Aufgaben

• Manage registration cases for product development projects and renewals.
• Monitor changes in official regulations with a country-specific focus.
• Coordinate registration activities across multiple regions.

Kenntnisse

Regulatory requirements knowledge

Project management expertise

Advanced communication skills in English

Cultural awareness

Self-management skills

Organizational skills

Interpersonal skills

Ausbildung

Diploma or Master’s degree in Engineering or related field

Jobbeschreibung

Senior Regulatory Affairs Manager (m/f/d)

Olympus Winter & Ibe GmbH (OWI) – Chief Quality Officer

As a high-tech specialist within the Olympus Corporation, Olympus Surgical Technologies Europe is the development and manufacturing center for rigid endoscopy, bipolar high-frequency surgery and reprocessing. With a total workforce of 2,600 employees at nine locations in EMEA and its headquarters in Hamburg, the company stands for exceptional performance in medical diagnostics and therapy, and offers a full range of the most modern endoscopic applications, from single products to procedure-oriented systems solutions.

Your Responsibilities

• Management of registration cases for product development projects and renewals
• Monitoring and interpretation of changes in official regulations with a country-specific focus
• Coordination of registration activities across multiple regions and support for distributors in preparing necessary documentation
• Support development of strategies for early access to market
• Develop and foster strong cross‑functional collaboration with key stakeholders, including R&D and regional RA counterparts
• Contribution to standards boards and assessment of cost and business impact of registration cases
• Presentation of regulatory topics to third parties and mentoring of junior team members on regulatory matters

Your qualification

• Diploma or Master’s degree in Engineering or a related field (or equivalent experience)
• 5+ years of experience in a highly regulated industry in RA, with involvement in at least 10+ registration projects
• Strong knowledge of regulatory requirements in specific markets and project management expertise
• Advanced communication skills in English
• Cultural awareness and the ability to adapt to diverse international markets
• Exceptional self‑management, organizational, and interpersonal skills
• Ability to explain complex regulatory concepts to non‑regulatory stakeholders and junior team members

Your benefits

• 30 days of annual leave
• Up to 60% mobile work possible + flexible work time model with overtime compensation
• Holiday and Christmas bonuses
• Corporate benefits discounts for employees
• Comprehensive company pension scheme and capital‑forming benefits
• Company restaurant with live cooking and healthy food (subsidized)
• Employee Assistance Program of FamPLUS to support your health, mental and emotional well‑being
• Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing
• Various subsidized company sports groups and access to the in‑house company gym

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.

Further information:

Your future inclusive workplace awaits

We value the diversity of individuals, perspectives, and lifestyles, and prioritize inclusion and mutual respect. We are committed to fostering a non‑discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.