Olympus Europa SE & Co. KG (OEKG)Medical Systems

Type of employment:

Permanent employment

Function:

Quality / Audit / Corporate Governance

Location:

Hamburg

Reference Number:

80212013-26052025

Website:

https://www.olympus-europa.com

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 competencies

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

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

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.

More reasons to join our team

Regulatory Affairs Manager (m/f/d) EU & Europe - limited to 2 years

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