About Teleflex Incorporated

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

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.

Principal Responsibilities

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.

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.

Specialized Skills / Other Requirements

Key Relationships/Interfaces
• VP of RAQA
• VP of RA
• Director RA, EMEA
• Global RA / Product Management RA
• Customer Service
• EMEA Commercial Teams

Behaviours/Values:
• Approachable and enthusiastic. Flexible and adaptable
• Good organizational skills with cultural awareness and sensitivity
• Good judgment and problem-solving ability and can understand the impact of decision making on both Teleflex Medical and their customers.
• Strong collaboration and influencing skills – both internally and externally
• Excellent communication skills – both verbal and written
• Goal orientated for customer and business objectives
• Coaching/Mentoring skills

Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities will evolve and change over time.

TRAVEL REQUIRED: Approx 20%

#LI-PD1 #LI-hybrid

Teleflex is an equal opportunity employer. Applicants will be considered without regard to age, gender, race, nationality, ethnicity, civil status, family status, sexual orientation, disability, religion and/or membership of the traveller community.
If you require accommodation and support to apply for a position, please contact us at talent.emea@teleflex.com.
Diversity fosters innovative thinking and entrepreneurship and that’s what we are about at Teleflex. We trust and value our people and their diversity and we make it fun to work here. We are on a journey to ensure our workplaces mirror the patients we serve and the communities we operate in. Our approach is simple, we embrace everyone and want them to feel they belong here. We are building a culture where all employees can bring their best and unique selves to work. If that appeals to you, we would love to hear from you. Come join a company where diversity is sought out and inclusivity is how we progress.

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.

Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
© 2025 Teleflex Incorporated. All rights reserved.

Regulatory Affairs Manager, EMEA

Job Description