Regulatory Affairs Specialist

Position Summary

Support the regulatory activities which lead to and maintain regulatory compliance and approval for Teleflex Medical products in the EMEA region

Principal Responsibilities

Key responsibilities will include (but are not limited to) the following:
•    Ensure compliance with EMEA regulatory requirements and applicable regulatory standards.
•    Coordinate and support regulatory and product registration activities for the EMEA region, including new product registrations, license amendments, renewals, and maintenance of existing approvals.
•    Prepare, compile, review, and maintain regulatory submission files and associated documentation for product registrations, tender applications, and other international market requirements.
•    Review Change Orders, change control documentation, and related technical documentation to assess potential regulatory impact on EMEA and regulatory submissions and approvals.
•    Provide timely regulatory affairs input to cross-functional projects, including new product introductions, product changes, process changes, and other business or regulatory initiatives.
•    Collaborate with Business Units, regional partners, distributors, and internal functional teams to support efficient and timely product registrations, and ongoing regulatory compliance.
•    Research and respond to regulatory queries from internal stakeholders and external parties, including distributors, and customers, and prepare supporting information for product shipment and market access activities.
•    Liaise with internal departments to ensure that accurate supporting technical, scientific, and quality data are generated, reviewed, and provided in a timely manner for regulatory submissions and compliance activities.
•    Support and/or coordinate Internal Part Number (IPN) reviews and Market Registration (MR) activities for the EMEA region, including creation, review, maintenance, and coordination of associated records.
•    Support Purchased Finished Device (PFD) verifications in accordance with applicable EU MDR requirements.
•    Support regulatory inspections, internal audits, and external audits as required.
•    Ensure ongoing Quality System compliance through adherence to internal procedures and applicable external regulatory requirements, and support alignment of local regulatory procedures with global procedures.
•    Keep informed of new and evolving regulatory requirements and developments relevant to the EMEA region and broader international markets.
•    Provide guidance, support, and day-to-day coordination for junior team members, where applicable.
•    Adhere to Teleflex’s Code of Ethics and all company policies, rules, procedures, and housekeeping standards.
•    Support other duties and regulatory activities as assigned by management.

Education / Experience Requirements

•    Degree in a relevant Science or Engineering discipline required.
•    3 years medical device industry experience within quality or regulatory essential.
•    Technical writing expertise.
•    Basic knowledge and understanding of EU and international medical device regulations, standards and guidance documents.
•    Project Management skills and experience.

Specialized Skills / Other Requirements

•    Self-driven and ability to work independently and/ or as a team player.
•    Approachable and enthusiastic. Flexible and adaptable.
•    Able to work on own initiative and as a team player.
•    Good organisational skills with cultural awareness and sensitivity.
•    Good judgment and problem-solving ability & capable of understanding the impact of decision making on both Teleflex and customers.
•    Excellent Communication skills both written and verbal. 
•    Interface with various departments as applicable for the project to ensure all regulatory deliverables are achieved.
•    Communicate concerns effectively to the RA Manager and project teams to ensure that they are addressed.
•    Participate in project meetings to provide regulatory inputs during the planning, execution and closure of the projects.
•    Pharmaceutical and/or Drug/ Device Combination device experience and Clinical expertise an advantage