Regulatory Quality Lead, SaMD – Equity & Impact

Adamant Health Oy; Helsinki; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Adamant Health Oy is seeking a hands-on Manager, Quality and Regulatory Assurance to own and continuously improve our QMS and act as PRRC as we scale across Europe. You will lead regulatory strategy, from technical documentation to product registrations, ensuring lifecycle compliance.

You will guide cross-functional teams, translate complex requirements into practical workflows, coordinate audits, CAPA, and drive continuous improvement to deliver safe, effective Parkinson’s care technology.

Qualifications

• Master’s degree in engineering, life sciences, software engineering, biomedical engineering or related field.
• At least five years of experience in Quality Assurance and/or Regulatory Affairs in the medical device industry.
• Strong knowledge of MDR (EU) 2017/745, ISO 13485, IEC 62304, ISO 14971 and FDA requirements.
• Experience as QMS owner or PRRC or in a similar leadership role.
• Experience preparing technical documentation and leading audits/inspections.
• Solid understanding of SaMD and hardware device regulation; capable in startup settings.

Responsibilities

• Own, maintain and improve the QMS in compliance with EU MDR, FDA and regional regs.
• Act as PRRC and primary contact for notified bodies and regulatory authorities.
• Lead regulatory activities: strategy, documentation, product registrations, submissions, lifecycle compliance.
• Plan internal audits, coordinate external audits and inspections, drive CAPA.
• Develop practical, scalable quality processes to support fast product development.
• Provide hands-on guidance to cross-functional teams and deliver training.
• Monitor regulatory changes and drive implementation across the organization.
• Lead and manage projects including clinical trials.

Skills

Quality Assurance

Regulatory Affairs

Project leadership

Stakeholder management

English proficiency

Education

Master’s degree in engineering, life sciences or related field

Tools

MDR (EU) 2017/745

ISO 13485

IEC 62304

ISO 14971

FDA requirements

Job description

Adamant Health Oy is seeking a hands-on Manager, Quality and Regulatory Assurance to own and continuously improve our QMS and act as PRRC as we scale across Europe. You will lead regulatory strategy, from technical documentation to product registrations, ensuring lifecycle compliance.

You will guide cross-functional teams, translate complex requirements into practical workflows, coordinate audits, CAPA, and drive continuous improvement to deliver safe, effective Parkinson’s care technology.