Senior Manager - International Regulatory Affairs (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

- Line management of the International Regulatory Affairs team.
- Support the development and execution of the global registration plan for portfolio within their responsibility.
- Collaborate with cross-functional stakeholders and global counterparts to achieve business outcomes and implement process improvements. Act as global registrations SME.
- Support global initiatives related to accelerating market access such as the Submission Excellence initiative and the development of global processes and playbooks.
- Support implementation of regulatory intelligence in processes within scope of responsibility.
- Collaborate with US counterpart to identify alignment and foster collaboration across global International RA SIS team.
- Support long term planning for the future of the global International RA SIS team, work with superior and counterpart to develop departmental strategies aligned with functional and company objectives.
- Ensure the continuous improvement of processes, organizational set up and resource management within team.
- Facilitate international cooperation to achieve departmental and global objectives.

Your qualification

- Diploma or Master’s degree in Engineering, MedTech, Science or a related field (or equivalent experience)
- 5+ years of experience in a highly regulated industry in RA
- Leadership experience (line management) within a matrix-organization preferred
- Strong knowledge of regulatory requirements in specific markets
- Advanced communication skills in English
- Cultural awareness and the ability to adapt to diverse international markets
- Exceptional self-management, organizational, and interpersonal skills

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 inhouse company gym