Clinical Regulatory Affairs Manager
vor 1 Woche
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
Do you want to work for an innovative specialist spinal implant company and play a pivotal role in advancing medical research?
**If yes, come to join our clinical studies team as Clinical Regulatory Affairs Manager**
(fixed term contract
- until the end of 2026)
**Your main responsibilities will be**:
- Managing Clinical Evaluation Reports for implantable medical devices.
- Supporting updates of annual PSURs, including annual PMCF plans, PMCF reports, user surveys, literature reviews.
- Supporting annual updates of SSCPs.
- Additionally, supporting process improvement initiatives associated with Clinical Evaluations, PMCF reports, User Surveys, and SSCPs.
**Your profile**:
- Over 5 years of experience in clinical evaluation writing, ideally in implantable medical devices, spine surgery: evaluation Reports, PMCF reports, SSCPs
- Expertise in literature reviews
- Recognized qualification in a clinical or medical field
- Advanced knowledge of the EU 2017/745 MDR regulatory framework
- Fluent in French and English, both are daily working language
- Strong organizational and interpersonal skills
**Job Types**: 100%, Fixed term
Contract length: 18 months
Schedule:
- Monday to Friday
Work Location: Hybrid remote in 1228 Plan-les-Ouates, GE
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