Regulatory Affairs Director

Vor 6 Tagen

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

We are seeking a highly skilled and experienced Head of Regulatory Affairs and Compliance to join our team at PAUL HARTMANN AG. As a key member of our organization, you will be responsible for ensuring compliance with all regulatory requirements of our entire product portfolio in all relevant markets.

Key Responsibilities
  • Regulatory Compliance: Ensure that our products meet all relevant regulatory requirements, including monitoring of specified standards and legal requirements.
  • Regulatory Strategy: Support the development and implementation of regulatory strategies within the framework of projects and strategic initiatives.
  • Team Leadership: Lead the divisional Regulatory Affairs department, comprising a team of six members.
  • Product Evaluation: Evaluate and define the proper regulatory strategy approach for each product.
  • Post-Market Surveillance: Manage, coordinate, and contribute to post-market surveillance, labeling, regulatory product documentation, conformity assessments for the respective business division.
  • Regulatory Processes: Contribute to the writing and reviewing of regulatory processes, ensuring that resources and activities are aligned with commercial objectives.
  • Regulatory Knowledge: Contribute to the clinical, biological, risk management, usability, standards & regulations management, for the respective business division.
Requirements
  • Education: A University degree in life science, natural science, or an equivalent qualification.
  • Experience: At least 5 years of relevant professional experience in a Regulatory Affairs role within an international company.
  • Qualifications: Qualification as PRRC according to MDR.
  • Regulatory Knowledge: Comprehensive knowledge of the regulatory requirements of medical devices (e.g. MDR, MDD, MPG/MPDG/MPSV, MEDDEV, EN ISO 13485, 21 CFR 820), as well as personal protective equipment and Invitro diagnostics related to product safety and risk management.
  • Leadership Skills: Proven experience in leading and developing a team.
  • Project Management: Strong project management skills, with a preference for experience in managing international projects.
  • Communication Skills: Excellent communication and collaboration skills, with experience working effectively with cross-functional stakeholders at all levels, including in a matrix organization.
  • Language Skills: Fluent written and spoken English and German.
What We Offer
  • Flexible Working Conditions: Flexible working hours and mobile working.
  • International Mobile Working.
  • Attractive Benefits: Attractive ways of combining work and family life, e.g. childcare subsidy, company vehicle incl. private usage, 30 days paid leave per year, plus special leave for exceptional life events, company pension plan with attractive employer contribution incl. matching model for deferred compensation, plenty of parking spaces, canteen with café bar, and ongoing offers in the employee shop.
  • Health and Fitness: Access to over 6000 fitness and yoga studios, swimming pools, as well as Crossfit and bouldering halls (EGYM Wellpass), various health and fitness offers, e.g. skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break, etc.
  • Job Bike Leasing.
  • Corporate Benefits: Attractive discounts on e.g. travel, fashion, and technology via our corporate benefits platform.

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