Regulatory Affairs Manager

Vor 2 Tagen

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

At HARTMANN, we're committed to delivering innovative solutions that make a difference in the lives of healthcare professionals and their patients. As a key member of our Regulatory Affairs team, you will play a critical role in ensuring the compliance and regulatory readiness of our products.

As a Regulatory Affairs Manager, you will be responsible for managing the global submission process for our medical devices, ensuring that all necessary documents are submitted to regulatory authorities in a timely and accurate manner. You will work closely with our global colleagues and sales partners to coordinate submission activities and ensure that all regulatory requirements are met.

Key responsibilities will include:

  • Managing the global submission process for medical devices, including the preparation and submission of regulatory documents
  • Coordinating submission activities with global colleagues and sales partners to ensure timely and accurate submission of regulatory documents
  • Ensuring compliance with regulatory requirements, including Regulation (EU) 2017/745 and ISO13485
  • Sharing best practices and engaging in close professional dialogue with the global RA team

To be successful in this role, you will need:

  • A university degree in a scientific or technical field or comparable
  • Initial experience in regulatory affairs in the medical devices environment
  • Knowledge of the regulatory requirements for medical devices, including Regulation (EU) 2017/745 and ISO13485
  • Fluent in English and good knowledge of German is an advantage

We offer:

  • Flexible working conditions, including flexible working hours and mobile working
  • International mobile working
  • Attractive ways of combining work and family life, including childcare subsidy
  • 30 days paid leave per year, plus special leave for exceptional life events, vacation pay, and special annual payment according to collective agreement
  • Company pension plan with attractive employer contribution, including 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, Crossfit, and bouldering halls (EGYM Wellpass)
  • Various health and fitness offers, including skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break, etc.
  • Job bike leasing
  • Attractive discounts on travel, fashion, and technology via our corporate benefits platform

If you're passionate about delivering innovative solutions that make a difference in the lives of healthcare professionals and their patients, we encourage you to apply for this exciting opportunity.

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