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Head of Regulatory Affairs Risk Prevention

vor 2 Monaten

Heidenheim, Deutschland PAUL HARTMANN AG Vollzeit

At HARTMANN, we're all in to help , care , protect and grow . We support healthcare professionals, that 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.

Join our team as

Head of Regulatory Affairs Risk Prevention (f/m/d)

DEU-Heidenheim

As the Head of Regulatory Affairs within our division Risk Prevention, you will be a member of the Divisonal Management Board, responsible for all regulatory requirements of the entire product portfolio. This portfolio includes medical devices, system and procedure packs, personal protective equipment, and commodities. In addition, you will play a key role in driving forward the regulatory strategy, as well as leading the regulatory affairs team of the division.

  • Responsible for ensuring compliance with all regulatory requirements of the entire product portfolio in all relevant markets of the division, including the monitoring of specified standards and legal requirement
  • Support the business division in the development and implementation of 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. Ensure that resources and activities are aligned with the commercial objectives.
  • Contribute to the clinical, biological, risk management, usability, standards & regulations management, for the respective business division
  • 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
  • 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

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