Regulatory Affairs Manager – Medical Devices (EMEA/LATAM) Remote

Laborie Medical Technologies Corp.; Netherlands; Remote; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Pension plan

Flexible working model

Company car where applicable

Job summary

Laborie Medical Technologies Corp. is seeking a Regulatory Affairs Manager to lead regulatory strategy across multiple product lines and regions. The role drives global market access and guides teams from development to launch, ensuring compliance with EU MDR and international requirements.

You will manage submissions, liaise with authorities, and mentor junior staff, while supporting lifecycle management and post-market activities in a rapidly evolving international environment.

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%.

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 strategy

Cross-functional collaboration

Project management

Written & verbal English communication

Global/regional focus

Education

Bachelor’s degree in Engineering / Life Sciences / Regulatory Affairs / related

Job description

Laborie Medical Technologies Corp. is seeking a Regulatory Affairs Manager to lead regulatory strategy across multiple product lines and regions. The role drives global market access and guides teams from development to launch, ensuring compliance with EU MDR and international requirements.

You will manage submissions, liaise with authorities, and mentor junior staff, while supporting lifecycle management and post-market activities in a rapidly evolving international environment.