Sr. Regulatory Affairs Specialist

Expected Travel: Up to 10%

Requisition ID: 9971

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

Interventional Urology – The Interventional Urology business unit of Teleflex is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. Our flagship product, the UroLift® System, is the #1 minimally invasive procedure in the U.S. for treating an enlarged prostate, also called Benign Prostatic Hyperplasia, or BPH.* It is a proven approach that does not require heating, cutting, or destruction of prostate tissue.1 Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

*U.S. 2022 estimates based on US Market Model 2022-24 (5-17-22 FINAL), which is in part based on data provided by Symphony Health PatientSource® 2018-21, as is and with no representations/warranties, including accuracy or completeness.
1. Roehrborn, Can J Urol 2017

 

Position Summary

The Senior Regulatory Affairs (RA) Specialist for European Union Medical Device Regulation (MDR) will be responsible for supporting execution to MDR compliance plans to ensure all applicable technical files (for devices ranging from class I to class III) meet the EU MDR requirements on schedule. The MDR RA Senior Specialist will partner with the other cross functional teams to provide regulatory feedback on all MDR project/design deliverables and to author/lead corresponding MDR submissions (including remediation activities identified during MDR submission reviews).

Principal Responsibilities

•    Review and understand gap assessments on Technical Files and Design Dossiers against MDR requirements. This will require a review of all technical documentation, including, but not limited to, design verification & validation protocols & reports, risk management files, usability protocols & reports, manufacturing process information, biocompatibility evaluation reports, list of applicable standards, list of general safety and performance requirements, declaration of conformity and clinical data.
•    Collaborate with MDR Project Manager (PM) to determine an implementation plan to complete updates to technical documentation. Support implementation with cross-functional execution of necessary RA deliverables.
•    Author EU MDR Technical Documentation Summaries (TDS) for submission to notified body per MDR compliance plan schedule.
•    Work with MDR PM, RA staff, and all applicable MDR program work stream leads to ensure technical documentation update timelines are aligned.
•    Support the collection and provision of data required to submit to EUDAMED, as deemed necessary by MDR.
•    Provide input into other MDR workstreams, such as labeling, as required.
•    Participate in regulatory impact assessments as it relates to the MDR and relay the information to product specific Interventional Urology RA team member and/or design teams.
•    May serve as MDR RA team member for promotional materials review and product labeling as they relate to MDR registration and commercialization of medical devices.
•    Support, as required, new product development teams to assure collection of appropriate data for MDR regulatory submissions and compliance.
•    Identify use of appropriate international standards for carrying out remediation activities.
•    Monitor MDR government agency laws and regulations through websites, publications, and MDR team meetings, and relay updates to Interventional RA team members.
•    Determine issues which may create regulatory obstacles, questions/issues; investigate and propose solutions; escalate to MDR PM and Business Unit (BU) Management, as necessary.
•    Provide guidance to RA staff as related to the MDR project.
•    Interact with Notified Bodies as required to support MDR submissions and certifications.
•    Provide other departmental support as requested by immediate supervisor.
•    Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures, and housekeeping standards.
 

Education / Experience Requirements

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