Regulatory Specialist : FDA & Global Compliance - Full Time Hybrid

We are looking for a Regulatory Specialist:  FDA & Global Compliance to join our team. This role is pivotal in ensuring regulatory compliance of our Software as a Medical Device (SaMD) products across the US and international markets. The position will focus on FDA regulatory activities, including pre-submissions, 510(k), and DeNovo pathways, while also supporting MDR compliance, QMS processes, and global regulatory strategy.

As part of a growing team, this role offers the opportunity to shape regulatory processes, support clinical and product development, and contribute to the company’s expansion into new markets and certifications.

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)

US Compliance & Reimbursement

• 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

MDR & International Regulatory

• 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)

Quality Management System (QMS)

• 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

Audits & Compliance

• Support internal, external, and notified body audits
• Perform risk assessments and usability evaluations
• Support supplier/distributor evaluation and compliance processes

Cross-functional Collaboration

• 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

Continuous Improvement

• 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)
• SaMD (Software as a Medical Device)
• ISO 13485 and ISO 14971
• 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.