Aktuelle Jobs im Zusammenhang mit Vice President of Regulatory Affairs - Heidenheim an der Brenz, Baden-Württemberg - PAUL HARTMANN AG - Karriere


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Vice President of Regulatory Affairs

vor 3 Monaten


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 associated with our comprehensive product portfolio, which encompasses medical devices, system and procedure packs, personal protective equipment, and other commodities.

Key Responsibilities:

  • Ensure adherence to all regulatory standards for the complete product range across relevant markets, including continuous monitoring of established standards and legal requirements.
  • 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 appropriate regulatory strategies for each product.
  • Oversee, coordinate, and contribute to post-market surveillance, labeling, regulatory documentation, and conformity assessments for the division.
  • Participate in drafting and reviewing regulatory processes.
  • Engage in clinical, biological, risk management, usability, and standards & regulations management for the division.

Qualifications:

  • A degree in life sciences, natural sciences, or a related field.
  • A minimum of five years of relevant experience in a Regulatory Affairs capacity within an international organization.
  • Certification as PRRC in accordance with MDR.
  • Extensive knowledge of regulatory requirements pertaining to medical devices (e.g., MDR, MDD, MPG/MPDG/MPSV, MEDDEV, EN ISO 13485, 21 CFR 820), personal protective equipment, and in-vitro diagnostics regarding 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 within 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.
  • 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, and ongoing employee shop offers.
  • Access to over 6000 fitness and wellness facilities, including swimming pools and specialized fitness classes.
  • A variety of health and wellness programs, including skin cancer screenings, mental health online 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 focused on healthcare customers, designed for the future, and rooted in a culture of trust and transparency.