Regulatory Affairs Manager

Laborie; Hengelo; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance group discounts

Company car where applicable

Pension plan

Paid time off and volunteer time

Job summary

Laborie is seeking a Regulatory Affairs Manager to lead regulatory programs for multiple product lines across EMEA, LATAM and other international markets. You will develop and execute strategies, guide cross-functional teams through development and commercialization, and manage submissions and market access activities.

The role requires strong English communication, 7+ years in regulatory affairs for medical devices, and experience with EU MDR (2017/745).

Qualifications

• Excellent written and verbal communication skills in English.
• Strong project management, analytical, and problem-solving skills.
• Experience interacting with regulatory authorities and notified bodies.
• Experience working within a regulated quality management system environment.
• 7+ years regulatory affairs experience in medical devices.

Responsibilities

• Act as the primary regulatory lead for multiple product lines and regions.
• Develop and execute international regulatory strategies for new products, changes, and lifecycle management.
• Lead regulatory submissions, registrations, renewals, and market access activities across EMEA, LATAM, and other regions.

Skills

Project management

Analytical thinking

Problem solving

English communication

Education

Bachelor's degree in Engineering/ Life Sciences/ Biomedical Sciences/ Regulatory Affairs

Job description

We believe that great healthcare is an essential safeguard of human dignity.

At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.

We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.

Who We’re Looking For:

As a key member of the Regulatory team, the Regulatory Affairs Manager will

Act as the primary regulatory lead for multiple product lines and geographic regions, independently managing complex regulatory projects while influencing cross-functional decision. The Regulatory Affairs Manager significantly impacts Laborie's ability to maintain global market access, particularly in the EMEA and LATAM regions, and enhances the ability for Regulatory Affairs to execute regulatory strategy and achieve business growth objectives in international markets.

About the Role:

• Develop and execute international regulatory strategies supporting new product introductions, product changes, and lifecycle management activities.
• Provide regulatory guidance to cross-functional teams throughout product development and commercialization.
• Assess regulatory pathways, submission requirements, timelines, risks, and mitigation strategies for international markets.
• Lead and support regulatory submissions, registrations, renewals, and market access activities across EMEA, LATAM, and other international regions.
• Prepare, compile, review, and submit regulatory dossiers and supporting documentation as required.
• Manage interactions with regulatory authorities, notified bodies, authorized representatives, and international distributors.
• Support compliance with the European Medical Device Regulation (EU MDR 2017/745).
• Contribute to the development and maintenance of technical documentation and post-market regulatory activities.
• Monitor global regulatory developments and provide recommendations regarding emerging regulatory requirements.
• Assess the regulatory impact of design, manufacturing, labeling, software, supplier, and process changes for international markets.
• Support regulatory assessments related to complaints, adverse events, recalls, corrective actions, and field safety activities.
• Serve as a key regulatory contact for international distributors and regional commercial teams.
• Participate in regulatory inspections, audits, and external assessments.
• Lead complex regulatory projects and mentor less experienced regulatory professionals.

Minimum Qualifications:

• Bachelor's degree in Engineering, Life Sciences, Biomedical Sciences, Regulatory Affairs, or a related scientific discipline.
• 7+ years of regulatory affairs experience within the medical device industry.
• Experience managing international product registrations and regulatory submissions.
• Working knowledge of EU MDR (2017/745) requirements.
• Experience supporting Class II and/or Class III medical devices.
• Experience interacting with regulatory authorities and notified bodies.
• Experience working within a regulated quality management system environment.
• Strong project management, analytical, and problem-solving skills.
• Excellent written and verbal communication skills in English.
• Ability to manage multiple priorities and deadlines in a global environment.
• Willingness to travel internationally up to approximately 5-10%.

Why Laborie:

Our Mission every day is to operate as a world‑class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.

• Paid time off and paid volunteer time
• Health i nsurance g roup d iscounts
• Company car w h ere applicable
• Pension plan
• Flexible working model in an international team

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.