Regulatory Affairs Specialist

Vor 7 Tagen


Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit
Lead Regulatory Affairs Expert

We support healthcare professionals, enabling them to focus on what truly matters: positively impacting people's lives. As the Head of Regulatory Affairs within our Risk Prevention division, you will be a key member of the Divisional Management Board, responsible for ensuring compliance with all regulatory requirements across our entire product portfolio.

Key Responsibilities:

  • Ensure compliance with regulatory requirements for medical devices, system packs, personal protective equipment, and commodities in all relevant markets.
  • Develop and implement regulatory strategies within project frameworks and strategic initiatives.
  • Lead the Regulatory Affairs department, comprising a team of six members.
  • Collaborate with international teams to drive forward regulatory strategies.

Requirements:

  • At least 5 years of experience in Regulatory Affairs within an international company.
  • Comprehensive knowledge of medical device regulations.
  • Strong project management skills, with a preference for international project experience.
  • Fluent written and spoken English and German.

Benefits:

  • International mobile working.
  • Attractive work-life balance options.
  • Private usage of company resources.
  • 30 days paid leave per year, plus special leave for exceptional life events.
  • Company pension plan with attractive employer contribution.
  • Various health and fitness offers.
  • Job bike leasing.
  • Attractive discounts on travel, fashion, and technology.


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