Director of Regulatory Affairs and Risk Management

vor 4 Wochen

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

At PAUL HARTMANN AG, our mission is to support , care for , protect , and develop innovative solutions that enhance the lives of individuals. We empower healthcare professionals to concentrate on what truly matters: making a positive impact on people's lives. Your dedication will allow you to grow in your role every day. We believe in the significant difference you can contribute.

We invite you to become a part of our team as

Head of Regulatory Affairs Risk Prevention (f/m/d)

In this pivotal role, you will be an integral member of the Divisional Management Board, overseeing all regulatory obligations across our comprehensive product range. This includes medical devices, system and procedure packs, personal protective equipment, and various commodities. Furthermore, you will be instrumental in advancing our regulatory strategy while leading the regulatory affairs team within the division.

  • Ensure adherence to all regulatory standards for the complete product portfolio across all relevant markets, including the oversight of established standards and legal obligations.
  • Collaborate with the business division to devise and execute regulatory strategies aligned with project frameworks and strategic initiatives.
  • Lead the Regulatory Affairs department, managing a dedicated team of six professionals.
  • Assess and determine the appropriate regulatory strategy for each product.
  • Oversee, coordinate, and contribute to post-market surveillance, labeling, regulatory documentation, and conformity assessments for the respective business division.
  • Participate in the drafting and evaluation of regulatory processes, ensuring that resources and activities align with commercial objectives.
  • Engage in clinical, biological, risk management, usability, and standards & regulations management for the respective business division.
  • Hold a university degree in life sciences, natural sciences, or an equivalent qualification.
  • Possess a minimum of 5 years of relevant experience in a Regulatory Affairs position within an international organization.
  • Have qualifications as PRRC in accordance with MDR.
  • Demonstrate extensive knowledge of regulatory requirements pertaining to medical devices (e.g., MDR, MDD, MPG/MPDG/MPSV, MEDDEV, EN ISO 13485, 21 CFR 820), as well as personal protective equipment and in-vitro diagnostics related to product safety and risk management.
  • Exhibit proven experience in leading and developing teams.
  • Showcase strong project management capabilities, preferably with experience in managing international projects.
  • Possess excellent communication and collaboration skills, with a track record of effective engagement with cross-functional stakeholders at all levels, including within a matrix organization.
  • Be fluent in both written and spoken English and German.
  • Enjoy flexible working conditions, including adaptable working hours and mobile working options.
  • Benefit from international mobile working opportunities.
  • Access attractive work-life balance options, such as childcare subsidies.
  • Utilize a company vehicle for private use.
  • Enjoy 30 days of paid leave annually, in addition to special leave for significant life events.
  • Participate in a company pension plan with favorable employer contributions, including a matching model for deferred compensation.
  • Take advantage of ample parking, a canteen with a café bar, and ongoing offers in the employee shop.
  • Gain access to over 6000 fitness and yoga studios, swimming pools, as well as Crossfit and bouldering facilities (EGYM Wellpass).
  • Engage in various health and fitness initiatives, including skin cancer screenings, online mental health courses, massage services, and yoga during lunch breaks.
  • Explore Job Bike Leasing options.
  • Enjoy attractive discounts on travel, fashion, and technology through our corporate benefits platform.

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