QA/RA Team Lead for SaMD — Regulatory Strategy & Leadership

Thirona BV; Nijmegen; Hybride; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Hybrid work

Remote work up to 8 weeks/year

27 vacation days

8% holiday allowance

8% pension

Résumé du poste

Thirona BV is seeking a Team Lead QA/RA to set the direction for quality and regulatory affairs in a small, fast-growing company. You will coach and develop the team, translate business ambitions into a QA/RA strategy, and be the go-to partner for management on quality topics.

You will work closely with R&D, operations and commercial teams to embed quality thinking in everyday decisions, shaping the QMS to be compliant yet practical in a fast-moving, AI-driven medical software environment.

Qualifications

• 7+ years of experience in the medical device field and its regulatory landscape.
• Experience obtaining 510(k) clearance and MDR certification for medical devices; software-based medical devices is a plus.
• Solid understanding of ISO 13485 and ISO 14971.
• Strong verbal and written English communication skills.

Responsabilités

• Lead the QA/RA team: set priorities, divide the work and support each team member’s growth.
• Define and drive the QA/RA strategy and roadmap in line with product pipeline and business goals.
• Advise management on regulatory pathways, compliance risks and required resources, and report on QMS performance.
• Represent Thirona towards notified bodies, regulatory authorities and auditors.
• Stay hands-on across CAPA, complaint handling, risk management, supplier qualification, audits and continuous QMS improvement.

Connaissances

Leadership

QA/RA

Regulatory affairs

ISO 13485

SaMD

English fluency

Formation

Higher education

Description du poste

Thirona BV is seeking a Team Lead QA/RA to set the direction for quality and regulatory affairs in a small, fast-growing company. You will coach and develop the team, translate business ambitions into a QA/RA strategy, and be the go-to partner for management on quality topics.

You will work closely with R&D, operations and commercial teams to embed quality thinking in everyday decisions, shaping the QMS to be compliant yet practical in a fast-moving, AI-driven medical software environment.