Expected Travel: None
Requisition ID: 12589
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.
Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.
Position Summary
Principal Responsibilities
1. Support generation and maintenance of Technical Files/Technical Documentations and regulatory submissions to U.S. FDA, EU-NB, Health Canada. Responsible for ensuring the files are in compliance with relevant regulations and standards.
2. Participate in and ensure compliance with design controls and review design documentation to confirm regulatory requirements are met.
3. Support the organization in change control activities for potential impact on current regulatory filings for U.S. FDA, EU-NB, Health Canada. Prepare regulatory assessment/submissions as appropriate.
4. Support regulatory agency and/or notified body audits by as needed.
5. Participate in development and approval of risk activities as well as other deliverables as related to projects.
6. Review and approve Clinical Evaluation, PMCF, SSCP development and updates to achieve regulatory compliance.
7. Provide regulatory input to product lifecycle planning.
8. Support regulatory tasks and strategic initiatives, and recommend solutions to address potential regulatory and quality issues.
9. Review and approval of all labeling (product, advertising and promotional), considering potential regulatory impact, and clinical evaluations.
10. Support CAPAs, NCs, and other quality efforts, as needed.
11. Assist in regulatory due diligence process, as needed.
12. Lead departmental SOP development and implementation and maintain regulatory files as required by departmental procedure.
13. Monitor impact of evolving global regulations regarding submissions, practices, and procedures and to regulatory processes and internal stakeholders.
14. Support RA Manager with other regulatory tasks and initiatives. Propose solutions for Regulatory Affairs questions/issues to RA management, as necessary
15. Oversee product registration, tender and license applications.
16. Prepares monthly reports to RA management
17. Adhere to Code of Ethics for Regulatory professionals.
18. Comply with Teleflex’s Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
19. Undertake effective OSH measures to ensure compliance, within the workplace, with the Occupational Safety and Health Act 1994 and other legislative requirements
Education / Experience Requirements
• A Bachelor’s Degree in Science or Engineering field is preferred. Bachelor’s degrees in other disciplines may be acceptable with equivalent experience.
• 2-5 years of experience in medical device and regulatory affairs or equivalent experience
• Must be able to demonstrate strong experience with technical files/design dossiers, global regulatory submissions i.e. MDR, 510(k), Health Canada licenses, and other international submission requirements.
• Must have experience with all aspects of design controls
• Working knowledge of Quality Assurance/ Quality Engineering is preferred
Specialized Skills / Other Requirements
• Strong communication skills
• Strong attention to detail & analytical thinking skills
• Strong ability to apply technical solutions to problem solving
• Strong interpersonal, technical writing and organizational skills
• Ability to prioritize and manage multiple projects to meet deadlines with minimal oversight
• Ability to analyze and resolve non-routine regulatory issues using independent judgement
• Orientation to teamwork, problem solving ability, customer focus, and a commitment to quality
• Ability to comply with business and Regulatory Affairs ethical standards.
• Proficient in Microsoft Word, Excel, Power Point, and Outlook required
• Knowledge of electronic document management systems
Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time.
Teleflex is an equal opportunities employer.
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.
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