Regulatory Affairs Specialist

vor 2 Monaten

PlanlesOuates, Schweiz Spineart SA Vollzeit

SPINEART is a privately held medical device company based in Geneva, Switzerland, focused on simplifying the surgical act by designing, developing, and promoting safe and efficient solutions to spine surgeons, operating room teams, and patients.

Selling in over 60 countries, Spineart is a pioneer in its field, having introduced unique technologies in the fields of Minimally Invasive Surgery, Motion Preservation, Fusion, Biologics and Fracture Treatment.

Spineart markets a complete portfolio combining traceable barcoded sterile packed implants with compact instrument sets, thus proudly promoting greater safety, cost-efficiency, and compliance at the hospital.

Our success also depends on our team’s value. The human being is at the centre of our concerns. We pay special attention to our recruitment to make Spineart a great place to work.

For us, soft skills are as important as hard skills. What we expect from our employees is nothing short of real team spirit, mutual assistance, and self-transcendence.

Our philosophy: Quality, Innovation, Simplicity

Our values: Respect, Integrity, Solution oriented

Are you a Regulatory Affairs Specialist interested in taking the next step in your career and ready to join a company that values innovation and excellence?

Do you want to work for a fast-growing spinal implant company and be a key player in our mission to deliver top-tier products that make a difference?

If yes, come to join our Regulatory team to ensure adherence to local and international regulatory requirements

As Regulatory Affairs Specialist, you'll play a pivotal role in ensuring our products meet all necessary regulatory requirements. You'll collaborate with cross-functional teams and navigate complex regulatory landscapes.

Your main responsibilities will be to manage the regulatory activities required to market medical devices and maintain registrations worldwide:

  • Support the preparation and maintenance of the registration files.
  • Maintain regulatory databases up to date.
  • Monitor registrations’ lifecycle in the Registration Information Management System.
  • Participate in writing and updating MDR Technical Documentation.
  • Participate in writing 510(k) upon manager’s demand.
  • Work on cross-functional teams; R&D, marketing, and manufacturing to advise the regulatory impact of proposed regulatory changes & transfers.
  • Interact with foreign agents, distributors, and competent authorities to monitor and manage registrations’ lifecycle worldwide.
  • Support the preparation of PMS/PSUR reports for products.
  • Participate in internal audits and external audits from Notified Bodies or Foreign competent authorities.
  • Participation in RA survey through impact studies for new standards.
  • Participate in gathering, analysing, and interpreting Regulatory Metrics and Key Performance Indicators.

Your profile:

  • Minimum 3 years of recent experience in Regulatory Affairs.
  • Experience within medical device industry with expertise on the Medical Device Regulation.
  • Strong communication skills, with the ability to effectively convey information to diverse audiences.
  • Good writing skills (structured documentation such as protocols and reports).
  • Ability to document, compile and maintain complex files.
  • Able to work in English and French.

Job Types: 100%, Permanent

Work Location: In person

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