Clinical & Regulatory Affairs Specialist

vor 1 Woche

Biel, Bern, Schweiz Bien-air Surgery Sa Vollzeit

Bien-Air Surgery SA is a rapidly expanding international company specializing in the development, manufacturing, and marketing of cutting-edge instruments for microsurgery.

Having established a strong presence in the global market over the years due to our focus on creativity, innovation, and the exceptional quality of our products and services, we are now seeking to enhance our team at our Biel/Bienne and Le Noirmont locations with a:

CLINICAL & REGULATORY AFFAIRS SPECIALIST

Our Mission: Make a positive impact on patients' lives by ensuring the safe and effective market entry of our medical devices.

As a pivotal member of our team, the Clinical & Regulatory Affairs Specialist will be instrumental in navigating the regulatory landscape to bring our medical innovations to market while adhering to both national and international standards. This role will encompass the entire product lifecycle, from inception to post-market monitoring.



Responsibilities:
  • Regulatory Affairs:
    • Function as the "Person Responsible for Regulatory Compliance" (PRRC) as per Article 15 of EU MDR 2017/745
    • Ensure regulatory compliance on assigned projects
    • Manage technical file compliance
    • Supervise and validate market surveillance activities (PSUR and SSCP)
    • Prepare regulatory submission dossiers for new products, product modifications, or license renewals
    • Contribute to responses for notified bodies and competent authorities
    • Monitor regulatory updates and implement them internally
    • Handle audits related to regulatory matters
  • Clinical Evaluation:
    • Coordinate clinical evaluations with internal and external experts
    • Consolidate evaluation plans and reports
    • Conduct systematic literature reviews on relevant medical devices and clinical practices
    • Ensure timely submission of clinical study reports to regulatory bodies
    • Address audits regarding clinical aspects
  • Post-market Clinical Follow-up:
    • Develop and execute the PMCF plan in collaboration with stakeholders
    • Prepare the PMCF report

Profile:

  • Hold a Master's degree or equivalent in life sciences, engineering, or related fields (a Ph.D. is advantageous)
  • Minimum of 4 years' experience in clinical evaluations, medical writing, or clinical research within the medical device industry
  • Thorough understanding of national and international medical device regulations (ISO 13485, MDR 2017/745, MDSAP, FDA, etc.)
  • Proficient in systematic scientific literature research, clinical investigations, and medical writing
  • Experience with Class III medical devices is a bonus
  • Strong written and verbal communication skills
  • Ability to work autonomously and collaboratively
  • Excellent analytical and statistical abilities
  • Fluency in English (B2 minimum); knowledge of French or German is a plus

Our Benefits:

  • Warm and cooperative work environment within a close-knit team
  • Varied assignments offering diverse challenges
  • Direct contribution to the company's achievements and prosperity
  • Opportunities for professional growth and advancement
  • Flexible work schedules

If you meet the specified requirements, please submit your complete application via Jobup.

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