Regulatory Affairs Manager, MedTech (EU MDR) | Hybrid

Talents Solutions; Luik; Hybride; EUR 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Flexible remote work

Occasional Liège site visits

Résumé du poste

Talents Solutions, on behalf of a growing MedTech company in Belgium, seeks a Regulatory Affairs Manager to own regulatory strategy for Class III medical devices. You will oversee regulatory activities from development to market authorization in a hybrid Liège-based setup.

Fluent in French and English, you will coordinate with Notified Bodies and authorities, ensure EU MDR 2017/745 and ISO 13485 compliance, and drive international market access while combining strategic leadership with hands-on

Qualifications

• 5–10 years of Regulatory Affairs experience in the medical device industry.
• Strong expertise in EU MDR 2017/745 and ISO 13485.
• Experience with high-risk medical devices, ideally Class III.
• Experience in both pre-market and post-market regulatory activities.
• Solid knowledge of technical documentation, regulatory submissions and product registrations.
• Good understanding of PMS, PSUR, vigilance, CER and PMCF requirements.
• Experience interacting with Notified Bodies and regulatory authorities.
• Fluent in French and English (written and spoken).
• Autonomous, analytical and capable in an agile, multidisciplinary environment.

Responsabilités

• Regulatory Strategy & Compliance: Define and implement regulatory strategies for medical devices, including Class III products.
• Ensure compliance with EU MDR 2017/745 and applicable international regulatory requirements.
• Maintain and review technical documentation and EU Declarations of Conformity.
• Lead regulatory submissions, product registrations and international market access activities.
• Act as PRRC for regulatory compliance in accordance with MDR Article 15.
• Manage interactions with Notified Bodies and regulatory authorities.
• Post-Market Surveillance & Clinical Activities: Oversee PMS, vigilance and regulatory reporting activities.
• Prepare PSURs and support CER/PMCF activities.
• Cross-Functional Collaboration: Work with R&D, Quality, Clinical and Business Development teams; support ISO 13485.
• Monitor regulatory developments and coordinate priorities and budget.

Connaissances

Regulatory strategy

EU MDR knowledge

Cross-functional collaboration

Communication skills

Fluent French

Fluent English

Formation

Master's degree or PhD in science/engineering/regulatory discipline

Description du poste

Talents Solutions, on behalf of a growing MedTech company in Belgium, seeks a Regulatory Affairs Manager to own regulatory strategy for Class III medical devices. You will oversee regulatory activities from development to market authorization in a hybrid Liège-based setup.

Fluent in French and English, you will coordinate with Notified Bodies and authorities, ensure EU MDR 2017/745 and ISO 13485 compliance, and drive international market access while combining strategic leadership with hands-on