Regulatory Specialist : FDA & Global Compliance - Hybrid

Key Responsibilities FDA Regulatory Compliance

• 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

• Support MDR compliance and technical documentation
• Ensure alignment with ISO 13485 and ISO 14971 requirements
• Contribute to global regulatory strategy and future certifications (e.g. MDSAP Canada)

• 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)

• Bachelor's or Master's degree in Life Sciences, Engineering, Regulatory Affairs, or related field
• 7 years of experience in regulatory affairs (FDA focus)
• Experience with FDA submissions (510(k), DeNovo, Pre‑Sub)
• Experience with SaMD (Software as a Medical Device)
• Experience with ISO 13485 and ISO 14971
• Experience with MDR and EU regulatory framework
• Knowledge of clinical studies (retrospective & prospective)
• Understanding of US reimbursement landscape is a plus
• Experience with SOC2 / MDSAP is a plus
• Strong analytical and problem‑solving abilities
• High attention to detail
• Ability to manage multiple projects simultaneously
• Strong communication and stakeholder management skills
• Ability to work cross‑functionally in an international environment
• Excellent verbal and written English communication skills

• A chance to be part of an exceptional team driving innovation in healthcare
• 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