Key Skills

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 where 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.

Core Responsibilities

Develop and execute international regulatory strategies, lead submissions and registrations across EMEA, LATAM, and other markets, and guide cross-functional teams on regulatory requirements throughout product development and commercialization. Manage regulatory authority and notified body interactions, support EU MDR compliance and post-market activities, assess the impact of product and process changes, and lead complex projects while mentoring colleagues.

Requirements

Requires a bachelor's degree in a relevant scientific or engineering discipline and at least seven years of medical device regulatory affairs experience, including international registrations and submissions. Candidates should have working knowledge of EU MDR, experience with Class II and/or Class III devices and regulated quality systems, strong project and communication skills, and willingness to travel internationally approximately 5–10%.

Benefits

• Paid Time Off
• Paid Volunteer Time
• Health Insurance Group Discounts
• Company Car Where Applicable
• Pension Plan
• Flexible Working Model