Job Information
Teleflex Sr. Regulatory Affairs Specialist in Wyomissing, Pennsylvania
Sr. Regulatory Affairs Specialist
Date: Jun 26, 2024
Location: Wyomissing, PA, US
Company: Teleflex
Expected Travel : Up to 10%
Requisition ID :10403
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
The Sr. Regulatory Affairs Specialist (SRA) will develop US, EU, and Canada strategies, assessments and submissions for complex projects and review issues related to regulatory documents, investigations, product development planning and regulatory agency interaction. The SRA will assist in mentoring and development of Regulatory Specialists as part of the role.
Principal Responsibilities
• Conduct appropriate research using standards, guidance documents, previous assessments and other resources to develop strong regulatory assessments for the US, EU and Canada for new and modified products.
• Assume full responsibility for project submissions for 510(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation, and Canadian license submission/amendments.
• Communicate with Commercial RA to ensure timely notification of changes as appropriate. Partner with Commercial RA to support registration of product in foreign markets.
• Work with Quality, Operations, Engineering, and other internal groups to investigate and recommend solutions to address potential regulatory issues and impacts.
• Interact and negotiate with regulatory authorities during the development (i.e. Q-Sub, change notifications, etc.) and submission review.
• Support regulatory agency and/or notified body audits by as needed.
• Participate in and ensure compliance with design controls and review design documentation to confirm regulatory requirements are met.
• Participate in development and approval of risk activities as well as other deliverables as related to projects.
• Provide regulatory review for reporting activities required by EU MDR (i.e. post-market surveillance, reporting, etc.).
• Review and approve all Labeling (product, advertising and promotional) and ensure claims are substantiated.
• Assist in regulatory due diligence process as needed.
• Proactively drive RA project deliverables by collaborating cross-functionally and engaging with cross-business unit team members as needed.
• Monitor impact of changing evolving global regulations on submissions, practices and procedures and communicate to internal stakeholders.
• Brings Regulatory Affairs questions/issues to the attention of RA management.
• Comply with Teleflex’s Code of Ethics, all Company policies, rules, and procedures.
Education / Experience Requirements
• Bachelor’s degree in a science or engineering field, or equivalent work experience.
• 5+ years of Medical Device Regulatory Affairs experience, domestic and international. 3 years of experience with Class I, II or III medical devices.
• Proven history of successful domestic and/or international submissions.
Specialized Skills / Other Requirements
• Strong analytical and critical thinking skills.
• Strong verbal and writing communication skills.
• Ability to manage and prioritize multiple projects to meet deadlines that align with the BU’s objectives.
• Proven track record of working as a team player to overcome obstacles and complete tasks through collaboration.
• Proficiency in MS Office software programs
• RAC certification is a plus.
#LI-NR1
Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.
Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, 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.