Head of Regulatory Affairs and Compliance

vor 1 Woche

Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit
About the Role

We are seeking a highly skilled and experienced Head of Regulatory Affairs and Compliance to join our team at PAUL HARTMANN AG. As a key member of our organization, you will be responsible for ensuring compliance with all regulatory requirements for our entire product portfolio, including medical devices, system and procedure packs, personal protective equipment, and commodities.

Key Responsibilities
  • Develop and implement regulatory strategies to ensure compliance with relevant standards and legal requirements.
  • Lead the Regulatory Affairs department, comprising a team of six members, and provide guidance and support to ensure effective team performance.
  • Evaluate and define the proper regulatory strategy approach for each product, taking into account market requirements and commercial objectives.
  • Manage, coordinate, and contribute to post-market surveillance, labeling, regulatory product documentation, conformity assessments, and other regulatory activities for the respective business division.
  • Contribute to the development of regulatory processes and ensure that resources and activities are aligned with commercial objectives.
  • Collaborate with cross-functional stakeholders to ensure effective communication and coordination.
Requirements
  • A University degree in life science, natural science, or an equivalent qualification.
  • At least 5 years of relevant professional experience in a Regulatory Affairs role within an international company.
  • Qualification as PRRC according to MDR.
  • Comprehensive knowledge of regulatory requirements for medical devices, personal protective equipment, and in vitro diagnostics related to product safety and risk management.
  • Proven experience in leading and developing a team.
  • Strong project management skills, with a preference for experience in managing international projects.
  • Excellent communication and collaboration skills, with experience working effectively with cross-functional stakeholders at all levels, including in a matrix organization.
  • Fluent written and spoken English and German.
What We Offer
  • Flexible working conditions, including flexible working hours and mobile working.
  • International mobile working.
  • Attractive ways of combining work and family life, such as childcare subsidy.
  • Company vehicle with private usage.
  • 30 days paid leave per year, plus special leave for exceptional life events.
  • Company pension plan with attractive employer contribution, including a matching model for deferred compensation.
  • Plenty of parking spaces, canteen with café bar, and ongoing offers in the employee shop.
  • Access to over 6,000 fitness and yoga studios, swimming pools, CrossFit, and bouldering halls (EGYM Wellpass).
  • Variety of health and fitness offers, such as skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break, etc.
  • Job bike leasing.
  • Attractive discounts on travel, fashion, and technology via our corporate benefits platform.

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