Head of Regulatory Affairs and Risk Management

Vor 7 Tagen

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

At PAUL HARTMANN AG, we're committed to helping healthcare professionals care for their patients, protect them from harm, and grow their skills. We support our teams to focus on what matters most: making a positive impact on people's lives. We develop solutions that make a difference, and with your expertise, you can contribute to our mission every day.

Key Responsibilities:

  • Ensure compliance with all regulatory requirements for our product portfolio, including medical devices, system and procedure packs, personal protective equipment, and commodities, in all relevant markets.
  • Support the business division in developing and implementing regulatory strategies within project and strategic initiatives.
  • Lead the divisional Regulatory Affairs department, comprising a team of six members.
  • Evaluate and define the proper regulatory strategy approach for each product.
  • Manage, coordinate, and contribute to post-market surveillance, labeling, regulatory product documentation, conformity assessments, and resource allocation for the respective business division.
  • Contribute to writing and reviewing regulatory processes, ensuring alignment with commercial objectives.
  • Contribute to clinical, biological, risk management, usability, standards, and regulations management for the respective business division.
  • Requirements:
    • 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 (e.g., MDR, MDD, MPG/MPDG/MPSV, MEDDEV, EN ISO 13485, 21 CFR 820), 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.
    • Flexible working conditions, such as flexible working hours and mobile working.
    • International mobile working.
    • Attractive ways of combining work and family life, e.g., 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 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, e.g., skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break, etc.
    • Job bike leasing.
    • Attractive discounts on e.g., travel, fashion, and technology via our corporate benefits platform.

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