Senior Manager of Regulatory Affairs

vor 4 Wochen

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

About Us:

At PAUL HARTMANN AG, we empower healthcare professionals to concentrate on what truly matters: making a positive difference in people's lives.

Position Overview:

We are seeking a Head of Regulatory Affairs within our Risk Prevention division. As a vital member of the Divisional Management Board, you will oversee all regulatory obligations pertaining to our comprehensive product range, which includes medical devices, system and procedure packs, personal protective equipment, and commodities.

Key Responsibilities:

  • Ensure adherence to all regulatory standards across our entire product portfolio in relevant markets, including the monitoring of established standards and legal obligations.
  • Assist the business division in formulating and executing regulatory strategies aligned with project frameworks and strategic initiatives.
  • Lead the Regulatory Affairs department, managing a dedicated team of six professionals.
  • Assess and establish the appropriate regulatory strategy for each product.
  • Oversee, coordinate, and contribute to post-market surveillance, labeling, regulatory documentation, and conformity assessments for the business division.
  • Participate in drafting and reviewing regulatory processes.
  • Contribute to clinical, biological, risk management, usability, and standards & regulations management for the division.

Qualifications:

  • A degree in life sciences, natural sciences, or a related field.
  • Minimum of 5 years of relevant experience in a Regulatory Affairs role within an international organization.
  • Qualification as PRRC in accordance with MDR.
  • In-depth 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 related to product safety and risk management.
  • Demonstrated experience in leading and developing teams.
  • Strong project management capabilities, particularly in managing international projects.
  • Excellent 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 written and spoken English and German.

Benefits:

  • Flexible working arrangements, including adaptable hours and remote work options.
  • International mobile working opportunities.
  • Supportive measures for balancing work and family life, such as 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, including a matching model for deferred compensation.
  • Ample parking, on-site canteen with café bar, and ongoing employee shop offers.
  • Access to over 6000 fitness and wellness facilities, including swimming pools and specialized fitness centers.
  • Various health and wellness initiatives, including skin cancer screenings, online mental health courses, and yoga sessions during lunch breaks.
  • Job bike leasing options.
  • Exclusive discounts on travel, fashion, and technology through our corporate benefits platform.

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

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