Regulatory Affairs Manager

Newel Health

Regulatory Affair Manager responsible for regulatory strategy in certified SaMD and digital therapeutics. Collaborating across teams to ensure compliance and safety in product development.

Posted 7/5/2026full-timeRemote • 🇪🇺 Anywhere in EuropeMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Flexible work arrangements
Professional development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Technical Documentation PreparationRisk AssessmentClinical Evaluation ReportsGSPR ChecklistsCE Mark SubmissionsFDA ClearanceVigilance ReportingTrend AnalysisComplaint HandlingPost-Market Surveillance

Soft Skills

CommunicationCollaborationAdvisory Skills