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.

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)

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)

Requirements

• 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

Benefits

• 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