Head of Regulatory Affairs Risk Prevention

Vor 4 Tagen

Ulm, Baden-Württemberg, Deutschland HARTMANN Vollzeit
About the Role

We are seeking a highly skilled and experienced Head of Regulatory Affairs Risk Prevention to join our team at HARTMANN. As a key member of our divisional management board, you will be responsible for ensuring compliance with all regulatory requirements of our entire product portfolio, including medical devices, system and procedure packs, personal protective equipment, and commodities.

Key Responsibilities
  • Develop and implement regulatory strategies within the framework of projects and strategic initiatives
  • Lead the divisional Regulatory Affairs department, comprising a team of six members
  • Evaluate and define the proper regulatory strategy approach for each product
  • Manage, coordinate and contribute to the post-market surveillance, labeling, regulatory product documentation, conformity assessments for the respective business division
  • Contribute in the writing and reviewing of Regulatory processes
  • Contribute to the clinical, biological, risk management, usability, standards & regulations management, for the respective business division
Requirements
  • A University degree in life science, natural science or an equivalent qualification
  • At least 5 years of relevant professional experience in a Regulatory Affairs role within an international company
  • Qualification as PRRC according to MDR
  • Comprehensive knowledge of the regulatory requirements of medical device (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
  • Proven experience in leading and developing a team
  • Strong project management skills, with a preference for experience in managing international projects
  • Excellent communication and collaboration skills, with experience working effectively with cross-functional stakeholders at all levels, including in a matrix organization
  • Fluent written and spoken English and German
What We Offer
  • Flexible working conditions, such as flexible working hours and mobile working
  • International Mobile Working
  • 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
  • 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
  • Attractive discounts on e.g. travel, fashion and technology via our corporate benefits platform
About Us

At HARTMANN, we're all in to help, care, protect, and grow. We support healthcare professionals, so they can focus on what really matters: to positively impact people's life. We realize solutions that make a difference. And with your commitment, you can grow on your job every day. At HARTMANN, we believe in the difference you can make.

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