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Chief of Regulatory Affairs and Risk Assessment

vor 3 Monaten


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

About PAUL HARTMANN AG:

At PAUL HARTMANN AG, our mission is to support, protect, and enhance the lives of healthcare professionals and their patients. We are dedicated to creating solutions that truly make a difference in the healthcare sector. Your dedication and expertise can help us grow and innovate every day.

Position Overview:

We are seeking a Head of Regulatory Affairs for our Risk Prevention division. This pivotal role will place you on the Divisional Management Board, where you will oversee all regulatory obligations for our comprehensive product range, which includes medical devices, system and procedure packs, personal protective equipment, and various commodities.

Key Responsibilities:

  • Ensure adherence to all regulatory standards across our product portfolio in all applicable markets, including the monitoring of relevant legal requirements.
  • Assist the business division in formulating and executing regulatory strategies aligned with project goals and strategic initiatives.
  • Lead the Regulatory Affairs team, which consists of six dedicated professionals.
  • Assess and establish appropriate regulatory strategies for each product category.
  • Oversee and contribute to post-market surveillance, labeling, regulatory documentation, and conformity assessments for the division.
  • Participate in drafting and reviewing regulatory processes, ensuring alignment of resources and activities with commercial objectives.
  • Engage in clinical, biological, risk management, usability, and standards & regulations management for the division.

Qualifications:

  • A university degree in life sciences, natural sciences, or a related field.
  • A minimum of five 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), personal protective equipment, and in-vitro diagnostics concerning product safety and risk management.
  • Demonstrated experience in leading and developing teams.
  • Strong project management capabilities, particularly in managing international projects.
  • Exceptional communication and collaboration skills, with a proven ability to work effectively with cross-functional stakeholders at all levels, including in a matrix organization.
  • Fluency in both written and spoken English and German.

Benefits:

  • Flexible working arrangements, including adaptable hours and remote work options.
  • International mobile working opportunities.
  • Support for balancing work and family life, including childcare subsidies.
  • Company vehicle with private usage options.
  • 30 days of paid leave annually, plus additional leave for significant life events.
  • Company pension plan with attractive employer contributions and matching models for deferred compensation.
  • Ample parking, a canteen with a café bar, and ongoing employee shop offers.
  • Access to over 6000 fitness and wellness facilities, including yoga studios and swimming pools.
  • A variety of health and wellness programs, including skin cancer screenings and mental health courses.
  • Job bike leasing options.
  • Exclusive discounts on travel, fashion, and technology through our corporate benefits platform.

Join us in shaping a future-focused career in healthcare, built on a foundation of trust and transparency.