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Manager Regulatory Affairs Submission

vor 3 Monaten

Heidenheim, Heidenheim an der Brenz, Deutschland PAUL HARTMANN AG Vollzeit
Responsibilities:
  • In this role, you will act as a competent regulatory contact for business units, regions and international sales partners with regard to the global submission management of our product portfolio
  • You will be responsible for managing the necessary submission documents with a focus on countries outside the European Union / EFTA
  • You coordinate the submission activities with your global colleagues and sales partners
  • Furthermore, you will accompany and monitor the submission process from the application to the approval received
  • As part of the global RA team, you will share your best practices and engage in close professional dialogue
Qualifications:
  • Successfully completed a university degree in a scientific or technical field or comparable
  • You have initial experience in regulatory affairs in the medical devices environment
  • Ideally knowledge or experience in submission processes for medical devices on a global basis
  • Knowledge of the regulatory requirements for medical devices, e.g. Regulation (EU) 2017/745, ISO13485
  • Enjoy working in an international team
  • Fluent in English and good knowledge of German is an advantage
Benefits:
  • 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