Regulatory Affairs Manager

Laborie Medical Technologies; Hengelo; Remote; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Paid time off

Health insurance group discounts

Company car wherever applicable

Pension plan

Flexible working model in an intl team

Job summary

Laborie Medical Technologies Corp. seeks an experienced Regulatory Affairs Manager to lead international regulatory projects and strategy across multiple product lines and regions, including EMEA and LATAM.

You will independently manage complex submissions and interact with authorities, notified bodies, and distributors in a global context. You will guide teams through EU MDR 2017/745, lifecycle management, and post-market activities while mentoring junior staff and driving market access

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.
• Willingness to travel internationally up to approximately 5-10%.

Responsibilities

• 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.

Skills

Regulatory affairs

Project management

Cross-functional collaboration

English communication

Education

Bachelor's degree in a related scientific discipline

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.

• Competitive salary
• Paid time off and paid volunteer time
• Health insurance group discounts
• Company car wherever applicable
• Pension plan
• Flexible working model in an international team

#LI-REMOTE