Regulatory Affair Manager

newelhealth· Strategy
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🌍 Remote📍 RemotePermanent

About this role

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.
  • 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.


Why Join Newel Health

  • Shape the next generation of digital health solutions.
  • Work in a certified SaMD environment at the forefront of behavioral science and AI.
  • Collaborate with leading partners in Pharma, MedTech, and academic research.
  • Enjoy a remote-first culture, supported by cross-disciplinary teams passionate about patient outcomes.
  • Be part of an organization building scalable, evidence-based impact in chronic care management.

Frequently Asked Questions

Is the salary disclosed for the Regulatory Affair Manager position at newelhealth?
The salary for this Regulatory Affair Manager role at newelhealth is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Is the Regulatory Affair Manager job at newelhealth remote?
Yes, this Regulatory Affair Manager position at newelhealth is remote, with team members based in Remote. You can work from home or anywhere in the supported regions.
Is the Regulatory Affair Manager role at newelhealth full-time or part-time?
This is listed as a Permanent position. It is posted as a Regulatory Affair Manager role in the Strategy department at newelhealth.
Which team or department does the Regulatory Affair Manager at newelhealth belong to?
This Regulatory Affair Manager position is part of the Strategy department at newelhealth. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Regulatory Affair Manager position at newelhealth?
Click the "Apply Now" button on this page. You will be redirected to newelhealth's official application portal hosted on bamboohr where you can submit your application directly.
When was the Regulatory Affair Manager job at newelhealth posted?
This Regulatory Affair Manager position at newelhealth was posted on May 7, 2025. Apply as soon as possible — early applications are often reviewed first.
Regulatory Affair Manager
newelhealth
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