Compliance and Risk Prevention Lead

Vor 5 Tagen

Heidenheim an der Brenz, Baden-Württemberg, Deutschland HARTMANN Vollzeit

Job Summary

We are seeking a highly experienced and skilled professional to lead our Regulatory Affairs team and drive the development of our regulatory strategy. As the Head of Regulatory Affairs and Risk Management, you will be responsible for ensuring compliance with all regulatory requirements for our medical device portfolio, including monitoring of specified standards and legal requirements.

Key Responsibilities

  • Develop and implement regulatory strategies to ensure compliance with relevant regulations and standards
  • Lead the Regulatory Affairs team and provide guidance on regulatory matters
  • Evaluate and define the proper regulatory strategy approach for each product
  • Manage and coordinate post-market surveillance, labeling, regulatory product documentation, and conformity assessments
  • Contribute to the development of regulatory processes and ensure alignment with commercial objectives
  • Collaborate with cross-functional teams to ensure regulatory compliance and risk management

Requirements

  • University degree in life science, natural science, or 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, including MDR, MDD, MPG/MPDG/MPSV, MEDDEV, EN ISO 13485, and 21 CFR 820
  • 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
  • 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, including childcare subsidy
  • Company vehicle with private usage
  • Days paid leave per year, plus special leave for exceptional life events
  • Company pension plan with attractive employer contribution, including matching model for deferred compensation
  • Plenty of parking spaces, canteen with café bar, and ongoing offers in the employee shop
  • Access to over 6000 fitness and yoga studios, swimming pools, Crossfit, and bouldering halls (EGYM Wellpass)
  • Various health and fitness offers, including skin cancer screenings, online courses for mental health, massage offers, and yoga during lunch break
  • Job bike leasing
  • Attractive discounts on travel, fashion, and technology via our corporate benefits platform

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