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

OLYMPUS EUROPA SE & CO. KG; Hamburg; Hybrid; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

A leading global medical technology company is looking for a Regulatory Affairs Manager to oversee regulatory requirements and ensure compliance for market access in the EU and EFTA. With a minimum of 5 years in regulatory affairs, you will drive product registration and compliance efforts while working closely with cross-functional teams. The role offers flexible working hours, remote work opportunities, and a comprehensive benefits package including holidays, health support, and a modern office environment.

Leistungen

Flexible working hours

30 days of holidays per year

Employee restaurant

100% subsidized public transport ticket

In-house gym

Employee Assistance Program

Comprehensive company pension scheme

Childcare support

Bike leasing

Qualifikationen

• Minimum of 5 years of experience in Regulatory Affairs.
• Proven experience in managing regulatory submissions.
• Strong skills in IT and working with regulatory systems.

Aufgaben

• Serve as primary point of contact for regulatory requirements.
• Support registration of products and ensure compliance.
• Manage QMS processes and collaborate internally.

Kenntnisse

Interpersonal Skills

Regulatory Project Management

Communication Skills

IT Proficiency

Tools

Regulatory Information Management (RIM)

Product Lifecycle Management (PLM)

Quality Management System (QMS)

MS Office

Jobbeschreibung

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

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

- Minimum of 5 years of 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 skills
- 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

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.

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, visitwww.olympus-europa.com and
follow our LinkedIn account: linkedin.com/company/OlympusMedEMEA

Further information:

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.