Regulatory Affairs Manager
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Job Description
Regulatory Affair Manager responsible for regulatory strategy in certified SaMD and digital therapeutics. Collaborating across teams to ensure compliance and safety in product development.
Responsibilities:
- Own the preparation and submission of technical documentation for MDR compliance, including GSPR checklists, clinical evaluation reports, and risk assessments.
- Maintain product registration portfolios across EU and international markets, collaborating with notified bodies and competent authorities.
- Interpret and communicate regulatory requirements to internal teams and advise on labeling, software changes, and product updates.
- Partner with quality, engineering, and clinical teams to ensure regulatory requirements are implemented throughout development.
- Monitor evolving global regulations for digital health and provide strategic guidance to ensure long-term compliance.
- Establish and oversee post-market surveillance activities, including complaint handling, vigilance reporting, and trend analysis, to ensure ongoing product safety and compliance.
Requirements:
- 4+ years in regulatory affairs for medical devices or digital health, with direct experience in EU MDR and US FDA.
- Strong understanding of SaMD, ISO 13485, IEC 62304, IEC 62366 and risk management under ISO 14971.
- Experience leading CE mark submissions, FDA clearance and interacting with notified bodies.
- Fluent in English; additional EU languages a plus.
Benefits:
- Flexible work arrangements
- Professional development
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