Regulatory Affairs Consultant (m/f/n) - Active Medical Devices

Projektmanager in der Zulassung von Medizinprodukten

We are searching as soon as possible for a dedicated and experienced

Regulatory Affairs Consultant (m/f/n) - Active Medical Devices

Projektmanager in der Zulassung von Medizinprodukten

  • Bereich:


  • Berufssparte:

    Zulassung/Regulatory Affairs

  • Arbeitsregion:

    Großraum Mannheim

  • Art der Anstellung:


  • Kennziffer:


  • Aktualisierung:


Your tasks

  • Preparation of regulatory documents in compliance with regulatory standards
  • Auditing according to EN ISO 13485 and 93/42/EEC or 90/385/EEC (Focus on active medical devices)
  • Developing / compiling technical files and design dossiers
  • Maintenance of contacts with the clients and regulatory authorities (e.g. Interactions with notified bodies)
  • Strategic planning and preparation of regulatory submission documents, interpretation of regulations and compliance with regulatory guidance
  • Support of the management with implementation of strategies and policies
  • Ability to travel locally and internationally, as required

Your qualifications

  • Educated to degree level (engineering / Master of Science) or with an equivalent combination of qualification and experience
  • Strong knowledge of regulatory guidelines: Medical Device Directive (MDD) - Directive 93/42/EEC and amendments and EN ISO 13485, EN ISO 14971, EN ISO 10993 series, EN 60601-1, EN 62304, EN 62366, etc.)
  • Working experience of at least 3 years in the Medical Devices sector
  • Excellent interpersonal, verbal and written communication skills as well as a strong customer focus
  • Excellent language skills in German and English (spoken and written); additional language skills would be an asset
  • Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail and strong organizational skills

Your benefits

  • You will be working in a modern, professional, fast-growing, internationally active organisation with a high degree of responsibility and independence
  • Intensive on-the-job training will be provided in a competent multidisciplinary team
  • We support the compatibility of work and family by offering flexible working hours as well as childcare subvention
  • Our academy offers various training opportunities
  • We offer the opportunity to participate in the company pension scheme
  • Under specific conditions you have the chance to participate in the employee participation program

Your contact person

Bettina Cöppicus
Senior Personalberaterin


Optares ICM GmbH & Co. KG
Bettina Cöppicus
Heiligengeist Höfe 8
26121 Oldenburg