WANTED: Manager, Quality and Regulatory Assurance (PRRC)

Adamant Health Oy; Helsinki; Hybrid; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality Assurance

Regulatory Affairs

Project leadership

Stakeholder management

English proficiency

Ausbildung

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

Tools

MDR (EU) 2017/745

ISO 13485

IEC 62304

ISO 14971

FDA requirements

Jobbeschreibung

WANTED: Manager, Quality and Regulatory Assurance (PRRC)

Adamant Health is a health-tech AI company entering a scale-up phase on a mission to revolutionize the care of Parkinson’s disease through data-driven disease management, enabling an earlier detection of motor symptoms and contributing to better patient outcomes. Founded in 2020 as a university spin-off, our CE-marked data-analysis technology delivers detailed, accurate symptom data that supports continuously optimized, personalized treatment. Our customers are public and private healthcare providers, and we aim to achieve rapid growth in the upcoming years.

We are looking for a hands‑on Manager, Quality and Regulatory Assurance to lead our Quality Management System (QMS) and act as our Person Responsible for Regulatory Compliance (PRRC) as we scale. Take ownership of quality and regulatory compliance and help bring life‑changing Parkinson’s care technology safely to patients across Europe.

This is a pivotal role at the heart of our compliance and product integrity, where you will own and continuously improve our QMS, act as our PRRC, and be the primary point of contact for notified bodies and regulatory authorities. You will lead our regulatory strategy end‑to‑end – from technical documentation to product registrations and lifecycle compliance – while building practical and scalable quality processes that support innovation rather than slow it down. In addition, you will lead projects with a strong regulatory dimension, including clinical trials.

What you will do

Own, maintain and continuously improve our QMS in compliance with the EU MDR, US FDA requirements, and other applicable regional regulations.

Act as our PRRC and serve as the primary contact for notified bodies and regulatory authorities.

Lead regulatory activities, including regulatory strategy, technical documentation, product registrations, regulatory submissions, and compliance throughout the product lifecycle.

Plan and conduct internal audits, coordinate external audits and inspections, and drive CAPA and continuous improvement activities.

Develop practical, scalable quality processes that support innovation and efficient product development in a fast‑paced start‑up environment.

Provide hands‑on quality and regulatory guidance to cross‑functional teams, deliver training, and translate regulatory requirements into practical ways of working.

Monitor changes in applicable regulations and standards, assess their business impact, and drive implementation across the organization.

Lead and manage projects, including clinical trials.

What we are looking for

A master’s degree (or higher) in engineering, life sciences, software engineering, biomedical engineering, or another relevant discipline.

At least five years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.

Strong working knowledge of MDR (EU) 2017/745, ISO 13485, IEC 62304, ISO 14971, and FDA requirements and processes.

Experience acting as a QMS owner, PRRC, or in a similar Quality & Regulatory leadership role.

Experience preparing technical documentation and leading notified body and/or regulatory authority audits and inspections.

A strong understanding of, and experience with, Software as a Medical Device (SaMD) and modern software development practices, as well as a good understanding of hardware medical device regulation and practices.

A demonstrated ability to build, prioritize and execute Quality & Regulatory activities independently in a start‑up environment.

A pragmatic and hands‑on mindset, with the ability to combine strategic thinking with operational execution and an eye on business needs.

Excellent communication, collaboration and stakeholder management skills, with fluency in English; Finnish is considered an advantage.

Who you are

Self‑motivated and confident to voice your own views and challenge the status quo when it matters.

Well‑networked, with strong collaborative and interpersonal skills.

Able to plan and manage your own work independently.

Hands‑on and energized by getting into the detail without losing sight of the big picture.

What we offer

A meaningful role with direct impact on patient lives and the future of Parkinson’s care.

A competitive salary, complemented by employee stock options – in line with common start‑up practice.

A diverse, expert team and a high‑ambition, dynamic start‑up culture.

Freedom to organize and arrange your own work.

The chance to shape the quality and regulatory foundations of an internationally scaling health‑tech business from an early stage.

Are you ready to help us change the way Parkinson’s disease is treated? We would love to hear from you.