POSITION SUMMARY

The Regulatory Affairs (RA) Manager is responsible for leading the EMEA Regulatory Affairs executing function, with accountability for the development and execution of regional regulatory strategies, oversight of Economic Operator responsibilities under EU MDR, and the management of product registrations and notifications across applicable markets. This role ensures regulatory compliance, drives cross-functional collaboration, and supports business objectives. The RA Manager also plays a key role in mentoring and developing team members, managing performance, and fostering a culture of continuous improvement and regulatory excellence.

EDUCATION / EXPERIENCE REQUIREMENTS

• Minimum 5 – 7 years expereince in a similar role and medical device background
• Degree in Regulatory, Biomedical Engineering or Science related discipline
• Strong understanding of relevant regulations and guidelines.
• Excellent verbal and written communication skills.
• Ability to manage multiple projects and deadlines effectively.
• Ability to analyse regulations and assess their impact.
• Meticulous in preparing and reviewing documentation.
• Ability to identify and resolve compliance issues.
• Ability to guide and motivate a team.
• A relevant degree in life sciences, engineering or scientific qualification, Masters an advantage
• Experience in regulatory affairs within the medical device industry.

Key responsibilities will include (but are not limited to) the following:

• Provide strategic leadership and oversight for the International Regulatory Affairs team across the EMEA region, ensuring alignment with global regulatory objectives and business priorities.
• Serve as the designated delegate for the Person Responsible for Regulatory Compliance (PRRC), ensuring adherence to applicable EU and international regulatory obligations.
• Ensure that all products, processes, and documentation comply with relevant global regulatory requirements, standards, and internal quality systems.
• Develop, implement, and continuously refine regulatory strategies for new and existing products to support timely market access and business growth.
• Lead talent development initiatives within the Regulatory Affairs team, including recruitment, performance management, coaching, and succession planning.
• Foster strong collaboration with Business Unit (BU) and regional stakeholders to ensure efficient execution of global regulatory strategies and product launches.
• Provide regulatory oversight for product and process changes, including review of Change Orders and assessment of their impact on regulatory approvals and licenses.
• Approve and/or oversee the preparation of regulatory submissions for new product introductions, renewals, and variations in the EMEA region.
• Monitor evolving regulatory requirements and proactively assess their impact on the business, ensuring timely communication and implementation of necessary changes.
• Collaborate with global regulatory counterparts and technical experts to address complex regulatory challenges and respond to inquiries from health authorities.
• Act as a regulatory point of contact for internal departments and external stakeholders, including distributors, providing guidance and resolution of regulatory issues.
• Lead and support regulatory inspections and audits at the site, ensuring readiness and effective response to findings.
• Manage regulatory projects, including planning, resource allocation, risk mitigation, and budget oversight, to ensure timely and successful outcomes.