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(Senior) Regulatory Affairs Manager (m/w/d)

  • Location: Germany
  • Salary: €75000 - €90000 per annum per year
  • Job Type:Permanent

Posted about 1 month ago

  • Sector: Medical Technology
  • Contact: Daniel Perkins
  • Contact Email: d.perkins@sciproglobal.de
  • Start Date: ASAP
  • Expiry Date: 18 September 2021
  • Job Ref: DP 240660_1629381303

(Senior) Regulatory Affairs Manager - Substance Based Medical Devices (m/w/d)

Are you interested in working in an owner-managed, family-orientated, medium-sized organization? Do you enjoy short decision-making paths and the freedom to implement your own ideas? Is a hands-on approach to leadership appealing to you? If your answer to these questions is yes, then look no further!

Your responsibilities as the new (Senior) Regulatory Affairs Manager:

  • The preparation of international approval documents for substance-based medical devices (OTC class I - II), and the corresponding European and International registration processes.
  • The review and approval of approval documentation.
  • The maintenance of the company's regulatory compliance.
  • Relevant contact person for notified bodies/authorities, and internal/external customers regarding regulatory-related topics.
  • Responsibility for acting as the company's PRRC (§15 MDR) for regulatory aspects (technical documentation, post-market surveillance, reporting obligations).
  • Entrusted with leading responsibilities in interdisciplinary projects, as well as the technical guidance of more junior colleagues.

What awaits you as the new (Senior) Regulatory Affairs Manager?

  • Flexible working arrangements.
  • The possibility to work remotely (up to 90%).
  • A strong sense of creative freedom, allowing you to use your strengths optimally.
  • The possibility to work with global leading, cutting-edge pharmaceutical and medical device organizations.
  • Extremely flat hierarchies, with short decision-making paths.
  • Working in a family-orientated, friendly environment.
  • International customers and varied tasks
  • Company pension scheme
  • Subsidized canteen, with access to free fruit and drinks.
  • In-house fitness programs.

The ideal Director (Senior) Regulatory Affairs Manager would have the following qualifications:

  • Successfully completed a university degree in a scientific or technical field (or compatible qualifications).
  • Several years of working experience within the field of regulatory affairs for medical devices at national and international levels.
  • An in-depth understanding of all relevant standards, regulations, and requirements (MDD/MDR, ISO 13485, etc.).
  • A flexible, entrepreneurial work style paired with a structured and analytical way of thinking.
  • Ability to assess regulatory risks/benefits and applicable guidance.
  • Excellent command of both the English and German languages.
  • Willingness to travel up to 10%

I am looking forward to receiving your application and learning more about your profile!