Clinical & Regulatory Affairs Specialist

vor 1 Woche

Biel, Bern, Schweiz Bien-Air Surgery SA Vollzeit

Bien-Air Surgery SA is a growing international company which develops, manufactures, and markets high-tech instruments for microsurgery. We have held an enviable position in the international market for many years thanks to our emphasis on invention and innovation, and the high quality of our products and services.

To support our team, we are looking to add to our team at our site in Biel/Bienne (and/ or Le Noirmont) a:

CLINICAL & REGULATORY AFFAIRS SPECIALIST

Mission:

Make a difference in patients' lives by ensuring our medical devices reach the market safely and effectively.

As a Clinical & Regulatory Affairs Specialist, you will play a crucial role in bringing our medical devices to market in compliance with national and international regulations. You will be involved in the entire product lifecycle, from its conception to post-market follow-up.

Responsibilities:

Regulatory Affairs:

  • Act as "Person Responsible for Regulatory Compliance" (PRRC), in accordance with Article 15 of EU MDR 2017/745
  • Manage activities and ensure regulatory compliance on assigned projects
  • Ensure technical file compliance
  • Supervise implementation and validate market surveillance activities (PSUR and SSCP)
  • Prepare regulatory submission dossiers for new products, product change or license renewal
  • Contribute to responses to notified bodies and competent authorities
  • Monitor regulatory changes and ensure their application internally
  • Respond to audits by notified bodies and competent authorities concerning regulatory aspects

Clinical Evaluation:

  • Coordinate clinical evaluations with internal and external experts
  • Consolidate evaluation plans and clinical evaluation reports (CEP, CER)
  • Plan and conduct systematic literature reviews on relevant medical devices and clinical practices
  • Ensure submission of clinical study reports to regulatory authorities
  • Respond to audits for clinical aspects by notified bodies and competent authorities

Post market clinical follow-up:

  • Define the PMCF plan, implement and monitor activities in collaboration with the various stakeholders (internal and external)
  • Write the PMCF report

Profile:

  • Master's degree or equivalent qualification in life sciences, engineering or related field. A PhD would be a plus.
  • At least 4 years' experience in clinical evaluations, medical writing or clinical research in the medical device sector.
  • In-depth knowledge of national and international regulations applicable to medical devices (ISO 13485, MDR 2017/745, MDSAP, FDA, etc.)
  • In-depth knowledge of systematic research of scientific literature, clinical research (clinical investigations) and medical writing
  • Experience in Class III medical devices would be a plus
  • Excellent written and oral communication skills
  • Ability to work independently and as part of a team
  • Strong analytical and statistical skills
  • Fluent in English (B2 minimum), any other languages such as French or German is a plus

Our Benefits:

  • Friendly, collaborative work environment in a family setting
  • Variety of assignments
  • Opportunity to contribute directly to the company's results and success
  • Development and career opportunities
  • Flexible working hours

Complete application dossier should be sent directly through Jobup.

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