Massachusetts Green Jobs

Sr. Regulatory Affairs Manager - Product Management

Date: Sep 26, 2024

Location: Remote, MA, US

Company: Teleflex

Expected Travel : Up to 10%

Requisition ID :11022

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.

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

The Senior Manager, Regulatory Affairs is an experienced leadership position with a deep understanding of global regulatory requirements, a strong track record in navigating complex regulatory landscapes, and the ability to collaborate across cross-functional teams. This position manages all aspects of regulatory affairs associated with the OEM business unit from writing technical files to design control and labeling reviews. The Senior Manager of Regulatory Affairs for Teleflex will lead regulatory strategies.

Principal Responsibilities

• Implementation of requirements for EU MDR, as needed, across the OEM BU.

• Oversee the development and execution of regulatory strategies for all of OEM, contract manufacturing, component level products, and private label for the US, Canada and CE Mark.

• Provide leadership for the team including performance management, Key Talent Development, succession planning, and employee development.

• Ensure compliance with product development and design control procedures during development activities.

• Oversee the preparation, review, and submission of regulatory documents to regulatory authorities, domestic and other international agencies, ensuring compliance with relevant regulations and guidelines.

• Manage negotiation and maintain interaction with regulatory authorities during the development and review/queries process to ensure submission approval and clearances.

• Interact with customer’s Regulatory Affairs representatives to determine strategies, support product registrations, and/or resolve issues.

• Ensure preparedness and support of regulatory agency audits, inspections, and interactions, including facilitating document requests, coordinating responses, and addressing findings.

• Monitor impact of changing evolving global regulations on submissions, guidance documents, best practices procedures and communicate to internal stakeholders.

• Maintain organized and up-to-date regulatory files, records, and documentation, ensuring accessibility and accuracy for internal and external stakeholders.

• Comply with Teleflex’s Code of Ethics, all Company policies, rules, procedures, and housekeeping standards.

Education / Experience Requirements

• Bachelor’s degree in science, engineering, or related field of study. Equivalent experience may be acceptable in lieu of a degree.

• 7 to 10 years of related Medical Device Regulatory Affairs with experience in Class I. II. and III devices, Class III experience is preferred.

• 5-7 years leadership experience including the proven ability to lead and motivate others.

• RAC certification is a plus.

• Previous experience working in OEM or contract manufacturing is preferred.

Specialized Skills / Other Requirements

• Experience with demonstrated leadership skills.

• Ability to apply business and Regulatory Affairs ethical standards

• Excellent analytical and critical thinking skills to develop creative solutions and meet objectives

• Strong verbal, written, and presentation skills

• Ability to partner with and influence others without direct authority, build consensus and look for collaboration with people from different departments and all levels, and manage multiple priorities and meet deadlines

• Proficient in MS Word, Excel, Power Point, and Outlook required

• Able to travel domestically and internationally.

The pay range for this position at commencement of employment is expected to be between (175,000 - 185,000 ) however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

#LI-EB1

Working Conditions / Physical Demands

TRAVEL REQUIRED: 10 %

WORKING ENVIRONMENT:

☒ Office/Professional ☐ Plant/Manufacturing ☐ Remote/Field ☐ Laboratory

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, 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™, 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.

© 2024 Teleflex Incorporated. All rights reserved.