Regulatory Specialist : FDA & Global Compliance - Full Time 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) 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) 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 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 #J-18808-Ljbffr Ikerian