Sr. Consultant RA / QA – Make an impact at young growing company!

Location:

Utrecht, Nederland, Netherlands

Salary:

Negotiable

Type:

Permanent

Main Industry:

Search Health, Nursing & Social Services Jobs

Advertiser:

NonStop Consulting

Job ID:

131771472

Posted On:

07 April 2025

QA/RA Consultant – Medical Devices

x1F4CD; Location: Utrecht region, The Netherlands (Hybrid)
x1F4C4; Employment Type: full time or 32 hours

About the Company

Join a dynamic and growing medical device consultancy specializing in Regulatory Affairs (RA) and Quality Assurance (QA). Based in the Utrecht region, we support innovative MedTech companies in bringing life-changing technologies to market while ensuring compliance with EU MDR, IVDR, FDA, and ISO 13485 regulations. Our approach is collaborative, hands-on, and tailored to the unique needs of each client-ranging from startups to established manufacturers.

The Role

As a QA/RA Consultant, you will play a crucial role in helping medical device companies navigate regulatory requirements and implement effective quality management systems. You will provide strategic guidance, support regulatory submissions, and ensure compliance with evolving medical device regulations.

Key Responsibilities:

Regulatory Affairs

* Develop and execute regulatory strategies for CE Marking (MDR/IVDR) and FDA submissions (510(k), PMA).
* Prepare and review Technical Documentation, risk management files, and regulatory dossiers.
* Act as a key liaison with Notified Bodies, Competent Authorities, and the FDA.

Quality Assurance

* Support the implementation and maintenance of ISO 13485-compliant Quality Management Systems (QMS).
* Conduct internal audits, supplier audits, and CAPA management.
* Ensure compliance with post-market surveillance (PMS) and vigilance requirements.

Client Support & Consultancy

* Advise MedTech clients on regulatory strategy, QMS implementation, and compliance best practices.
* Deliver training sessions and workshops on MDR, IVDR, ISO 13485, and risk management.
* Stay up to date with regulatory changes and provide proactive recommendations to clients.

What We’re Looking For:

x2705; 7+ years of experience in QA/RA for medical devices (consultancy experience is a plus).
x2705; Strong knowledge of EU MDR, IVDR, ISO 13485, FDA (21 CFR 820), and risk management (ISO 14971).
x2705; Experience in preparing Technical Documentation, CE Marking, and FDA submissions.
x2705; Ability to translate complex regulatory requirements into practical, business-friendly solutions.
x2705; Strong communication and stakeholder management skills.
x2705; Fluency in English (Dutch is a plus).

What We Offer:

x1F680; A chance to be part of a fast-growing consultancy with a strong reputation.
x1F4A1; Hybrid or remote work flexibility (based in the Utrecht region).
x1F30D; Work with innovative MedTech clients across Europe.
x1F4C8; Professional growth opportunities in an expanding industry.
x1F91D; A supportive, collaborative, and expert-driven environment.

Interested?

If you’re passionate about helping medical device companies succeed in regulatory and quality compliance, we’d love to hear from you!

x1F4E9; Apply now by sending your CV to (Your Contact Email) or connect with us to learn more.

Let me know if you’d like to tweak any details! x1F60A;

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