Regulatory Affairs Executive

Vor 5 Tagen

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 healthcare experience. We empower healthcare professionals to focus on their vital work of improving lives. Our innovative solutions are designed to make a significant impact, and your dedication can foster personal growth in your career.

Position Overview:

As the Head of Regulatory Affairs within our Risk Prevention division, you will hold a pivotal role on the Divisional Management Board, overseeing all regulatory obligations associated with our diverse 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.

Key Responsibilities:

  • Ensure adherence to all regulatory standards for the complete product portfolio across relevant markets, including the oversight of specified standards and legal requirements.
  • Assist the business division in formulating and executing regulatory strategies aligned with project goals and strategic initiatives.
  • Lead the Regulatory Affairs department, managing a 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 division.
  • Participate in drafting and reviewing regulatory processes, ensuring that resources and activities align with commercial objectives.
  • Contribute to 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 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), 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.
  • 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 included.
  • 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, a canteen with a café bar, and ongoing employee shop offers.
  • Access to over 6000 fitness and wellness facilities, including swimming pools and specialized fitness centers.
  • A variety of health and wellness initiatives, such as skin cancer screenings, online mental health courses, and lunchtime yoga sessions.
  • Job bike leasing options.
  • Exclusive discounts on travel, fashion, and technology through our corporate benefits platform.

Join us in shaping a career dedicated to healthcare customers, designed for the future, and rooted in a culture of trust and transparency.

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