Specialist Regulatory Affairs Operations and Labeling Expert

vor 1 Tag

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

About the Role:

We are seeking a highly skilled Specialist Regulatory Affairs Operations and Labeling Expert to join our team at PAUL HARTMANN AG. As a key member of our regulatory affairs team, you will be responsible for ensuring the labelling and implementation of products on time according to regulatory requirements.

Key Responsibilities:

  • Ensure the labelling and implementation of products on time according to regulatory requirements
  • Global monitoring and improvement of regulatory product documentation and conformity assessments
  • Responsible for the master files of the package inserts, labels and artwork and check them for correctness and the necessary labeling requirements in the review and approval process
  • Develop proposals to improve the IT infrastructure for the management of regulatory product documentation
  • Provide strategic and technical consulting on regulatory issues
  • Final evaluation of product-related regulatory requirements

Requirements:

  • University degree in science or technical sciences or an equivalent qualification
  • Ideally initial professional experience in the medical device environment or another regulatory field of work
  • Knowledge and/or experience in the areas of medical devices, technical documentation and regulatory product documentation, conformity assessment and post-market surveillance
  • Ideally a strong interest in and knowledge of electronic regulatory document control and management systems and associated processes
  • Open and competent attitude when working with internal partners
  • IT affinity and proficiency with the MS Office package
  • Strong communication skills as well as persuasiveness and assertiveness
  • Fluent written and spoken German and English

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
  • 30 days paid leave per year, plus special leave for exceptional life events as well as vacation pay and special annual payment according to collective agreement
  • 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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