Regulatory Affairs Manager

Talents Solutions; Luik; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Flexible remote work

Occasional Liège site visits

Job summary

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.

Responsibilities

• 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.

Skills

Regulatory strategy

EU MDR knowledge

Cross-functional collaboration

Communication skills

Fluent French

Fluent English

Education

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

Job description

Regulatory Affairs Manager – Medical Devices (Class III)

Location: Liège, Belgium | Hybrid / Flexible Remote Work
Contract: Permanent, Full-time
Start date: ASAP

About the Company

Talents Solutions is recruiting on behalf of an innovative and growing MedTech company based in Belgium, specializing in the development of advanced biomaterial-based medical devices.

Operating in a dynamic and international environment, the company combines scientific innovation, regulatory expertise and a strong commitment to improving patient outcomes.

We are looking for an experienced Regulatory Affairs Manager to take ownership of regulatory strategy and support the company's continued development and international market expansion.

The Role

Reporting directly to the CEO, you will be responsible for managing regulatory affairs activities throughout the entire medical device lifecycle, from product development and market authorization to post-market surveillance.

This position combines strategic responsibility with hands-on regulatory activities, requiring strong technical expertise, autonomy and the ability to collaborate effectively with multidisciplinary teams.

Key Responsibilities

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 Person Responsible for Regulatory Compliance (PRRC) for regulatory affairs activities, in accordance with MDR Article 15.
• Manage interactions with Notified Bodies and regulatory authorities.

Post-Market Surveillance & Clinical Activities

• Oversee post-market surveillance (PMS), vigilance and regulatory reporting activities.
• Prepare and maintain Periodic Safety Update Reports (PSURs).
• Support clinical evaluation activities, including CER and PMCF.
• Manage regulatory aspects of complaints, incident reporting and product recalls.
• Ensure regulatory information is maintained in EUDAMED.

Cross-Functional Collaboration

• Work closely with R&D, Quality, Clinical and Business Development teams.
• Provide regulatory guidance throughout product development.
• Support ISO 13485 compliance in collaboration with the Quality team.
• Monitor regulatory developments and assess their impact on products and business activities.
• Coordinate regulatory priorities and manage the regulatory affairs budget.

Your Profile

• 5–10 years of experience in Regulatory Affairs within the medical device industry.
• Master's degree or PhD in a scientific, engineering or regulatory-related discipline.
• Strong expertise in EU MDR 2017/745 and ISO 13485.
• Experience with high-risk medical devices, ideally Class III.
• Demonstrated 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 directly with Notified Bodies and regulatory authorities.
• Fluent French and English, both written and spoken.
• Autonomous, analytical and comfortable working in an agile, multidisciplinary environment.
• Strong communication skills and a pragmatic, business-oriented mindset.

Why Join?

• Take ownership of regulatory strategy with direct exposure to the CEO.
• Contribute to innovative medical technologies with a direct impact on patients.
• Combine strategic decision-making with hands-on regulatory responsibilities.
• Support European and international market expansion.
• Work closely with experienced R&D, Quality and Clinical teams.
• Join a growing and agile MedTech organization.
• Benefit from flexible remote working arrangements, with occasional visits to the Liège site.