Regulatory Affair Manager
Location: Remote (Europe-based preferred)
Type: Full-time
Industry: Digital Health, SaMD, DTx
Reports to: Head of Compliance
Position Overview
Newel Health is seeking a Regulatory Affair Manager to lead and execute regulatory strategy for our certified SaMD and digital therapeutics. In this role, you will be responsible for the preparation, submission, and maintenance of documentation required for CE marking, FDA clearance, DiGA inclusion, and global regulatory approvals. You will work cross-functionally with product development, clinical, and quality teams to ensure regulatory requirements are embedded into every stage of our SaMD lifecycle.
Key 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.
Required Qualifications
- 4+ years in regulatory affairs for medical devices or digital health, with direct experience in EU MDR and US FDA.
