Medical Device Regulatory Affairs Specialist

Vor 4 Tagen

Muri b Bern, Bern, Schweiz Compremium AG Vollzeit

**Job Overview**

We are seeking a highly motivated Clinical-Regulatory Program Manager to join our team at Compremium AG. As a key member of our regulatory affairs team, you will be responsible for ensuring the compilation of pre-submission and submission packages, preparing pivotal clinical trials, and supporting continuous interaction with regulatory authorities.

About Us:

Compremium AG is a medical diagnostics company based in Bern, Switzerland. We are dedicated to transforming the diagnosis of pressure-related conditions in the human body with our innovative platform technology.

Key Responsibilities:

  • Crafting regulatory submissions towards regulatory clearance of Compremium's Class II medical devices in multiple regions.
  • Crafting clinical trial submissions for multiple countries to provide strong evidence supporting regulatory clearance.
  • Supporting the continuous interaction with regulatory bodies, preparing interactive discussions, and ensuring timely delivery of Q&A packages.
  • Performing all work in compliance with relevant regulations, including ISO 13485, FDA, and EU MDR.
  • Providing training and support to staff on clinical and regulatory affairs.
  • Staying up-to-date with changes in regulatory requirements, guidelines, and industry best practices, and advising the organization on potential impacts.

Requirements:

  • A Master's degree in a related field (e.g., Biomedical Engineering, Life Sciences, Medicine).
  • Experience in the medical device field.
  • Experience in preparing and submitting regulatory documents and interacting with regulatory agencies (at least FDA and EU notified bodies).
  • Strong experience in designing and preparing medical device clinical trials in the US and Europe.
  • Strong understanding of medical device regulations and standards, such as FDA regulations (21 CFR), ISO 13485, and MDR.
  • Fast-learning ability.
  • Impeccable English; German and French working proficiency are a plus.

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