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Regulatory Affairs Manager (M/F/D)

Job description

Regulatory Affairs Manager (F/M/D)

Berlin- Fully remote

€40,000-70,000 + Holiday + Flexible working hours

Excellent opportunity for an experienced Regulatory Affairs Manager, who has a passion for working on socially good products and being part of a team that is creating an app which empowers people of over the world.

The company has created a personalized training app, that has helped their customers to stay brain healthy and happy for over 10 years. They have received awards from major health insurance companies, and have been award by Apple and Google as one of the best apps on the market.

The ideal candidate will be an experience Regulatory Affairs Manager, who is looking for a position where your role will touch many different fields and who want to develop themselves, given you have solid knowledge of MDR or MDD.
The role:

  • You will define the roadmap for he product to be successful as a Medical Device and be prescribed by specialists as a treatment for mild cognitive impairment.
  • Ensure compliance to relevant regulations, such as MDR / ISO 13485 / IEC 62304 / ISO 27001 / GDPR.
  • Actively work on definition and training of processes and documents for use in the relevant systems.
  • Actively collaborate with colleagues from IT / QA / Product / Science / Management and our regulatory consultants get approved by the BfArM on the German market, and to sustain this status
  • Continuously conduct Risk-Benefit analysis and ensure that all workstreams incorporate a risk management process.
  • Work closely with the Technology & Product Management departments

The person:

  • Bachelor's degree or higher
  • Excellent experience writing clean and compact technical documentation under MDR and ISO 13485
  • Excellent written and oral communication skills in English
  • Deep interest in digital health (e-Health) and the capabilities of the brain
  • Interest to develop your career towards a PRRC role, if not qualified yet
  • Nice to have experience with ISO 27001 (or other standards for maintaining an ISMS), GDPR
  • Nice to have knowledge of DiGAV in Germany

Reference Number: BBBH164143

To apply for this role or to be considered for further roles, please click "Apply Now" or contact Alexandra House at Rise Technical Recruitment.

Rise Technical Recruitment GmbH acts an employment agency for permanent roles and an employment business for temporary roles.

The salary advertised is the bracket available for this position. The actual salary paid will be dependent on your level of experience, qualifications and skill set. We are an equal opportunities employer and welcome applications from all suitable candidates.