Senior Regulatory Affairs Specialist

Date: Oct 5, 2021

Location: Remote, MA, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 4864

 

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.

 

OEM – Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

Responsible for managing all aspects of regulatory affairs associated with the OEM business unit, including but not limited to, change control, technical documentation review, labeling review, and design control review. This position will complete Regulatory Strategy documents and submissions; will be responsible for supporting and participating in the management of interactions with the US FDA, Health Canada, EU Notified Bodies, UK MHRA and other global regulatory authorities; and will support and participate in interactions with OEM customers’ Regulatory Affairs representatives to support global submissions and resolve issues. The Sr. Regulatory Affairs Specialist will also need to stay abreast of evolving global regulatory requirements.

Principal Responsibilities

•    Primary accountability for regulatory support, including preparation and maintenance of Regulatory strategies, 510(k) submissions, EU Technical Files, Canadian License applications for new and existing medical device products in the US, Canada, EU and other international markets. 
•    Collaborate with cross-functional teams and subject matter experts to maintain regulatory compliance, address questions from regulatory agencies and ensure timely implementation of regulatory strategies. 
•    Work directly with Regulatory Affairs Manager to promote agreement on filing strategies or address requests and questions from regulatory authorities.
•    Ensure timely submission approvals and product market release.
•    Provide guidance on Quality and Regulatory coverage, risks and requirements to the OEM customer care group.
•    Support regulatory compliance activities, including facility site registrations, audits, etc., as needed.
•    Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
•    Provide support and guidance to junior team members.
 

Education / Experience Requirements

•    Bachelor's degree and a minimum of 5 years of medical device regulatory experience OR an advanced degree with a minimum of 3 years of medical device regulatory experience.
•    Experience with the FDA Class II, EU Class IIb or EU Class III devices, preparing 510(k) submissions, technical files or design dossiers.
•    Broad medical device regulatory knowledge base, including global requirements for: submissions, marketing approvals, licensing, registrations, and renewals.
•    Knowledge and experience with design control, change assessment, labeling, etc. 
•    Experience working with cross-functional teams.

Preferred:
•    Experience preparing Health Canada license applications or other international submissions.
•    Knowledge and experience with Quality Systems, including complaint handling, adverse event reporting, recalls. 
•    Experience interacting with regulatory authorities relative to premarket and compliance activities. 
•    Regulatory certifications e.g., RAC, CQA, CQE, CQM
•    Project management experience.
•    Regulatory experience with contract manufacturing relationships.
 

Specialized Skills / Other Requirements

•    Strong analytical, research, problem solving, negotiating, technical writing, verbal/written communication, organizational, and time management skills.
•    Ability to work independently and effectively manage and prioritize numerous projects and responsibilities.
•    Must be flexible, able to adapt easily, and willing to take initiative and lead regulatory projects.
•    Proficient with Microsoft Office: Excel, PowerPoint, Outlook, Word.
•    Role is based remote with ability to work in the Mansfield, MA location no more than 50% of the time.

 

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: 262-439-1894.

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

© 2021 Teleflex Incorporated. All rights reserved.


Nearest Major Market: Boston