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 ResponsibilitiesFDA Regulatory CompliancePrepare and manage FDA submissions including 510(k), DeNovo, Pre-Submission, and Breakthrough DesignationEnsure completeness and compliance of all regulatory documentationCoordinate cross-functional inputs for submissions (clinical, risk, usability, technical documentation)US Compliance & ReimbursementSupport development of US reimbursement strategy (CPT codes, payer engagement)Ensure compliance with FDA, SOC2, and future MDSAP requirementsSupport SOC2 certification processes and data privacy/security complianceMDR & International RegulatorySupport MDR compliance and technical documentationEnsure alignment with ISO 13485 and ISO 14971 requirementsContribute to global regulatory strategy and future certifications (e.g. MDSAP Canada)Quality Management System (QMS)Maintain and improve QMS processes related to regulatory complianceReview promotional and training materials for regulatory complianceSupport design control, risk management, and documentation updatesAudits & ComplianceSupport internal, external, and notified body auditsPerform risk assessments and usability evaluationsSupport supplier/distributor evaluation and compliance processesCross-functional CollaborationWork with clinical teams on retrospective and prospective studiesCollaborate with R&D, product, and legal teams on regulatory requirementsSupport regulatory input in product development and change managementContinuous ImprovementImprove regulatory and quality processesSupport integration of compliance into development lifecycleMonitor regulatory landscape (FDA, MDR, global)RequirementsBachelor's or Master's degree in Life Sciences, Engineering, Regulatory Affairs, or related field7+ 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 14971MDR and EU regulatory frameworkKnowledge of clinical studies (retrospective & prospective)Understanding of US reimbursement landscape is a plusExperience with SOC2 / MDSAP is a plusStrong analytical and problem-solving abilitiesHigh attention to detailAbility to manage multiple projects simultaneouslyStrong communication and stakeholder management skillsAbility to work cross-functionally in an international environmentExcellent verbal and written English communication skillsBenefitsA chance to be part of an exceptional team driving innovation in healthcareA competitive salary in a supportive work environment that fosters work-life balanceOpportunities for professional growth and development in an international settingA culture of collaboration and inclusion, which is fundamental to our ethosOccasional travel to our HQ in Switzerland, immersing you in our core operations and company culture