Regulatory Affairs Manager (m/f/d) EU & Europe - limited to 2 years
Olympus Europa SE & Co. KG (OEKG)Medical Systems
Type of employment:
This position is limited to two years.
Your Responsibilities
- Serve as primary point of contact for regulatory requirements for the market access in the EU and EFTA- Support the registration of products across the EU, EFTA, and Europe
- Act as regulatory advisor during new product launches
- Conduct regulatory assessments for product launches
- Ensure compliance with applicable EU regulatory requirements
- Execute regulatory related projects within the EMEA region
- Close collaboration with relevant internal stakeholders such as R&D, Manufacturing, Supply Chain, and Quality - both regionally and globally
- Manage Quality Management System (QMS) processes and tools
Your qualification
- Relevant work experience in Regulatory Affairs, ideally within a matrix organization- Proven experience in regulatory project management support
- Experience in authoring and/or managing regulatory submissions (e.g., CE Mark, international)
- Ability to prepare regulatory submissions to support product commercialization (e.g., 510(k), CE Mark Technical File, international)
- Experience in managing and operating QMS processes and systems
- Understanding of global process flows and cross-functional collaboration
- Strong interpersonal skills with the ability to manage effective working relationships within Regulatory Affairs and with other departments (R&D, Manufacturing, Supply Chain, Quality, etc.)
- Excellent written and verbal communication skills in a multicultural and international environment
- Strong IT proficiency, including experience with regulatory systems (e.g., RIM, PLM), QMS platforms, and standard MS Office applications (Excel, Word, etc.)
Your benefits
- Flexible working hours, remote work possible (up to 60%)- 30 days of holidays per year
- Modern office and an inspiring working environment
- Employee restaurant with live cooking and healthy food (subsidized)
- Public transport ticket (100 % subsidized) or free parking space
- Company sport groups and an inhouse company gym
- Employee Assistance Program to support your health, mental and emotional well-being
- A comprehensive company pension scheme
- Company medical officer and vaccination offers
- Childcare through our ‘Buttje&Deern’ partner
- Bike leasing