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Regulatory Affairs Specialist (f/m/x)

Sysmex Europe Haematology

Hamburg

Hybrid

EUR 55.000 - 75.000

Vollzeit

Gestern
Sei unter den ersten Bewerbenden

Zusammenfassung

A healthcare technology company in Germany seeks a Regulatory Affairs Specialist to manage product registrations in the EMEA region. Ideal candidates will have a background in Biomedical Science, experience in regulatory affairs, and strong communication skills. This role supports compliance and documentation in a collaborative, hybrid work environment with excellent benefits.

Leistungen

30 days annual leave
Flexible working through flextime
In-house gym
Christmas and holiday bonuses
Relocation assistance

Qualifikationen

  • At least two years of hands-on experience in medical device technology within Regulatory Affairs.
  • Familiarity with IVDR Regulation (EU) 2017/746 and EUDAMED is a strong asset.
  • Excellent written and spoken English skills.

Aufgaben

  • Support product registrations across the EMEA region.
  • Monitor and communicate new regulatory requirements.
  • Provide regulatory documentation for tender submissions.

Kenntnisse

Detail-oriented
Collaboration with authorities
Customer-focused

Ausbildung

University degree in Biomedical Science or related field

Tools

Complex databases
Digital tools
Jobbeschreibung
Overview

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).

Responsibilities
  • 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.
  • 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)
Your profile

We are looking for a motivated and detail-oriented professional to join our team.

  • 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
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 environment with 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.

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