We are looking for a Regulatory Specialist: FDA & Global Compliance to join our team, responsible for ensuring regulatory compliance of our Software as a Medical Device (SaMD) products across the US and international markets.
Requirements
- Prepare and manage FDA submissions including 510(k), DeNovo, Pre-Submission, and Breakthrough Designation
- Ensure completeness and compliance of all regulatory documentation
- Coordinate cross-functional inputs for submissions (clinical, risk, usability, technical documentation)
- Support development of US reimbursement strategy (CPT codes, payer engagement)
- Ensure compliance with FDA, SOC2, and future MDSAP requirements
- Support SOC2 certification processes and data privacy/security compliance
- Maintain and improve QMS processes related to regulatory compliance
- Review promotional and training materials for regulatory compliance
- Support design control, risk management, and documentation updates
- Support internal, external, and notified body audits
- Perform risk assessments and usability evaluations
- Support supplier/distributor evaluation and compliance processes
- Work with clinical teams on retrospective and prospective studies
- Collaborate with R&D, product, and legal teams on regulatory requirements
- Support regulatory input in product development and change management
- Improve regulatory and quality processes
- Support integration of compliance into development lifecycle
- Monitor regulatory landscape (FDA, MDR, global)
Benefits
- A competitive salary in a supportive work environment that fosters work-life balance
- Opportunities for professional growth and development in an international setting
- A culture of collaboration and inclusion, which is fundamental to our ethos
- Occasional travel to our HQ in Switzerland, immersing you in our core operations and company culture
