Regulatory Affairs Manager (m/f/d) EU & Europe / limited contract

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Regulatory Affairs Manager (m/f/d) EU & Europe / limited contract, Hamburg

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Client:

Olympus

Location:

Hamburg, Germany

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

d92fa2c9f867

Job Views:

4

Posted:

23.06.2025

Expiry Date:

07.08.2025

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Job Description:

– 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

– Minimum of 5 years of experience in Regulatory Affairs, including leadership or management experience, 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 skills
– Strong IT proficiency, including experience with regulatory systems (e.g., RIM, PLM), QMS platforms, and standard MS Office applications (Excel, Word, etc.)

-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

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