Job Description
Are you looking for more than just a job, for something truly meaningful and rewarding? Then Sysmex Europe SE is the place for you. As the regional headquarters for the EMEA (Europe, Middle East and Africa) region, our company is dedicated to providing essential products that help people worldwide on their healthcare journey.
If this opportunity appeals to you, come and join us in the position of
Regulatory Affairs Specialist (f/m/x)
As Regulartory Affairs Specialist (f/m/x) you are responsible for supporting product registrations across the EMEA region, ensuring compliance with relevant regulatory requirements. The role also involves monitoring and communicating new or updated regulatory requirements, supporting affiliates during registration processes, and providing regulatory documentation for tender submissions.
Your key responsibilities include:
- Support our affiliates with the registration of our products in EMEA region
- Prepare and coordinate registration submissions
- Archive and maintain registration documents
- Perform EUDAMED registrations and fulfill Economic Operator Obligations in accordance with IVDR Regulation (EU) 2017/746
- Develop proficiency in any applicable regulatory requirement that applies to our products and ensure communication of new or changed requirements within the organization
- Provide support to tender offers (regulatory documents)
We are looking for a motivated and detail-oriented professional to join our team.
Ideally, you bring the following qualifications and strengths:
- Educational Background: You hold a university degree in Biomedical Science or a related field
- Industry Experience: You have at least two year of hands-on experience in the medical device technology sector within Regulatory Affairs
- Stakeholder Engagement: You have demonstrated experience collaborating with government authorities and distributors
- Regulatory Knowledge: Familiarity with the IVDR Regulation (EU) 2017/746 and EUDAMED is a strong asset
- Language Skills: You possess excellent written and spoken English skills
- Technical Proficiency: You are comfortable working with complex databases and digital tools
- Work Style: You are customer-focused and results-driven, multitasker while maintaining a meticulous and detail-oriented approach to your work
Location
In November 2025, we will be moving to the newly built "New-Work-Campus FLOW" in Hamburg-Eppendorf. Until then, the workplace for this position will be in Norderstedt.
See more information about the new campus here: https://www.alles-im-flow.de/
Our benefits
We are an aspiring corporate group where respect and trust form the basis for cooperation and communication within Sysmex.
Culture & cooperation
An appreciative work environment, open corporate culture, flat hierarchies and an inclusive and caring atmosphere. Working in an innovative and international environmentwith a broad learning and development landscape in our EMEA Campus, after-work events for internal networking
Work-life balance
Flexible working through flextime and a hybrid working model (60% mobile working, 40% on-site), 30 days annual leave
Additional benefits
Christmas and holiday bonuses, childcare allowance, capital-forming benefits, subsidy for company pension scheme, corporate benefits, relocation assistance, subsidised lunch in our canteen
Health & wellbeing
In-house gym, various sports courses, massages, company medical and psychological care, workplace glasses, general health management
Mobility
Subsidy for the public transport “Deutschlandticket”, free parking, bike leasing via JobRad
Social Responsibility
Various opportunities to get involved in different sustainability and charity initiatives, climate friendly and respectful use of resources
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