Regulatory and Quality Manager

QARA Manager (Quality Assurance & Regulatory Affairs)

About PointCaré

Anesthesiologists and intensivists work with a constant stream of monitoring data, lab results and patient records, often under intense time pressure. PointCaré develops ontarget, a clinical decision support platform for perioperative and critical care that combines real-time patient data with medical knowledge to help care teams anticipate, understand and act.

ontarget is developed within the framework of the EU Medical Device Regulation (MDR). That makes quality and regulatory work a core part of how we build, not something that comes afterwards.

The role

As QARA Manager, you own our quality management system and the regulatory strategy for our medical device software. You make sure the product meets all applicable requirements, both before and after it reaches the market. You report directly to the CEO and take quality and regulatory decisions on their merits, independently of commercial or development pressure.

What you will do

Quality management system

• Maintain and further develop our QMS in line with ISO 13485, keeping processes proportionate, workable and effective
• Act as management representative, reporting on QMS performance and promoting quality awareness across the organisation
• Own document and record control, internal audits and supplier qualification
• Manage nonconformities, CAPA and change control
• Prepare and lead management reviews, notified body audits and inspections by competent authorities

Regulatory affairs

• Define and maintain the regulatory strategy, including classification and conformity assessment route
• Compile and maintain the technical documentation, declaration of conformity and registrations
• Coordinate clinical evaluation together with our CMO
• Review labeling, product information and promotional material against the intended purpose and approved claims
• Monitor changes in regulation, guidance and standards, and assess their impact

Risk, post-market surveillance and vigilance

• Own the risk management framework in line with ISO 14971, integrated across the product lifecycle
• Lead post-market surveillance, complaint handling and vigilance, including reportability decisions and regulatory reporting
• Work with the CTO on information-security obligations that affect product quality and compliance

Your mandate

This role comes with real authority. You approve QMS procedures and can require their application by every team. You can halt a release or change when quality or regulatory requirements are not met, approve or reject technical documentation and regulatory submissions, and you have direct access to top management on any matter affecting product safety or compliance.

Who you are

• Degree in Engineering, Life Sciences, Pharmaceutical Sciences, Law or a related field
• Proven experience in quality assurance and regulatory affairs for medical devices, ideally software as a medical device
• Solid working knowledge of ISO 13485, ISO 14971, IEC 62304 and the MDR, including conformity assessment and notified body interaction
• Experience establishing or maintaining a QMS in a small or scaling company
• Experience with clinical evaluation, post-market surveillance, vigilance and complaint handling
• Sound judgement and the confidence to hold your position on a quality or regulatory matter, even under pressure

What we offer

• A key role in how our product is developed and brought to market in a compliant way
• Being part of a growing multidisciplinary team of clinicians, engineers and data scientists
• Real impact and ownership
• An office at the Wintercircus in Ghent, with hybrid working
• A competitive, market-aligned salary package, complemented by extra-legal benefits such as meal vouchers, hospitalisation insurance, laptop



How to apply

Send your CV and a short motivation to info@pointcare.be.