Regulatory Affairs Specialist

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

Sysmex provides global healthcare support with diverse medical diagnostics products and solutions. With more than 50 years' experience in in-vitro diagnostics, we improve the patients' healthcare journey.

Sysmex Europe SE, in Hamburg, Germany, is a regional headquarter for Europe, Africa and the Middle East and serves affiliates, distributors, and customers with over 2,500 employees in the EMEA region, living our mission "Together for a better healthcare journey " every day.

Hamburg Hamburg

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)

Leonie Nolte

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Reference No.: 10925

Sysmex Europe SE, Deelböge 19D, 22297 Hamburg

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

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

Did we spark your interest? Then we look forward to receiving your application with salary requirements and the earliest possible starting date.