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Chief of Regulatory Compliance for Risk Mitigation

vor 3 Monaten


Ulm, Baden-Württemberg, Deutschland HARTMANN Vollzeit

At HARTMANN, our mission is to support, care, protect, and develop healthcare solutions that make a significant impact on people's lives. We empower healthcare professionals to focus on what truly matters: enhancing patient outcomes. With your dedication, you can advance in your career every day. We believe in the positive difference you can make.

We invite you to join our team as:

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

In this pivotal role, you will be part of the Divisional Management Board, overseeing all regulatory obligations for our comprehensive product range. This includes medical devices, system and procedure packs, personal protective equipment, and various commodities. You will also be instrumental in shaping our regulatory strategy and leading the regulatory affairs team within the division.

Key Responsibilities:

  • Ensure adherence to all regulatory standards for the entire product range across relevant markets, including monitoring of specified regulations and legal requirements.
  • Assist the business division in crafting and executing regulatory strategies aligned with project frameworks and strategic initiatives.
  • Lead the Regulatory Affairs department, managing a 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 alignment of resources and activities with commercial objectives.
  • Engage in clinical, biological, risk management, usability, and standards & regulations management for the respective business division.

Qualifications:

  • A university degree in life sciences, natural sciences, or a related field.
  • A minimum of 5 years of relevant experience in a Regulatory Affairs position within an international organization.
  • Qualification as PRRC in accordance with MDR.
  • Extensive knowledge of regulatory requirements for 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 concerning product safety and risk management.
  • Proven track record in leading and developing teams.
  • Strong project management capabilities, preferably with experience in managing international projects.
  • Excellent communication and collaboration skills, with a history of effective interaction with cross-functional stakeholders at all levels, including in a matrix organization.
  • Proficiency in written and spoken English and German.

Benefits:

  • Flexible working arrangements, including adaptable working hours and remote work options.
  • Opportunities for international mobile working.
  • Attractive options for balancing work and family life, such as childcare subsidies.
  • Company vehicle with private usage included.
  • Generous paid leave policy, along with special leave for significant life events.
  • Company pension plan with competitive employer contributions, including a matching model for deferred compensation.
  • Ample parking facilities, a canteen with a café bar, and ongoing employee shop offers.
  • Access to over 6000 fitness and yoga studios, swimming pools, as well as Crossfit and bouldering facilities (EGYM Wellpass).
  • Various health and wellness programs, including skin cancer screenings, online mental health courses, massage services, and yoga sessions during lunch breaks.
  • Job bike leasing options.
  • Attractive discounts on travel, fashion, and technology through our corporate benefits platform.

Shape a career that prioritizes healthcare customers, is future-ready, and rooted in a culture of trust and transparency.