Sr. Manager, Regulatory Affairs

Date: Oct 8, 2021

Location: Maple Grove or Remote US, MN, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 4891

 

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.

 

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. Manager, Regulatory Affairs, MDR will focus on the strategy and execution of the Medical Device Regulation (MDR) for the Teleflex Global Regulatory Affairs team. This role will be responsible for management of regulatory affairs activities related to the implementation of MDR which include a broad set of activities as described below.
This role is responsible for partnering with cross-functional partners to maintain a scalable, strategically appropriate and maintainable regulatory affairs program for the Teleflex MDR Program. This role supports the Global RA/QA teams in Corporate and cross-BU MDR Implementation.
 

Principal Responsibilities

•    Represent the Global Regulatory Affairs function at the leadership level in cross-BU MDR Implementation
•    Build, develop and oversee MDR regulatory affairs resources, creating and maintaining a functional RA team structure that can effectively and efficiently support the needs of multiple Business Units. 
•    Provide guidance and training on the MDR regulation, strategic regulatory planning, and regulatory support of MDR-adjacent initiatives.
•    Management and development of staff.  Ensure that regulatory positions are staffed with qualified, motivated employees.  Ensure that reports are appropriately trained and have the resources necessary to do their assigned jobs.  Provide reports with career development opportunity and help them to realize their career goals.
•    Provide direction and leadership with respect to regulatory strategy and execution.
•    Liaise closely with R&D, marketing, clinical and QE/QA teams to ensure a clear understanding of regulatory requirements and understand the needs of these functions to achieve the most prudent path to MDR certification.
•    Oversee activities required to obtain market authorizations in the EU, including development of regulatory strategies, appropriate market authorization pathways,
•    Facilitate communications with regulatory agencies and notified bodies.
•    Other miscellaneous regulatory activities such as providing regulatory input MDR transition, including labeling and promotional materials review and product testing related to regulatory approvals and modification assessment.
•    Create regulatory policies, procedures and other quality system documentation as required.
•    Communicate the requirements of MDR to the rest of the organization.
•    Maintain strong relationships with Business Units
 

Education / Experience Requirements

•    B.S. Degree with 7 or more years of medical device QARA experience, and prior leadership of teams of 4-10 regulatory affairs professionals.
•    Broad regulatory knowledge base including global requirements for:  marketing approvals, change assessment; complaint handling; adverse event reports; recalls; labeling; and quality systems.
•    Regulatory certifications preferred, e.g., RAC, CQA, CQE, CQM
•    Proven experience working with FDA and/or EC Notified Bodies, HPRA (IR) and MHRA (UK).
•    Proven experience with 510(k)’s, technical files and Canadian device licenses.
•    Experience preferred – working with multiple country specific regulations/standards, i.e. EU MDD/MDR, China CFDA, MDSAP requirements (US, Canada, Brazil, Australia and Japan)
 

Specialized Skills / Other Requirements

•    Strong regulatory affairs knowledge, specifically of the EU Medical Device Regulation
•    Leadership/management skills
•    Customer service/complaint handling and problem-solving skills
•    Computer literate (word processing, spreadsheets, databases)
•    Documentation skills, negotiating skills and the ability to communicate effectively
•    Research, logic and technical writing skills
•    Presentation/training skills
Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems/conflicts
 

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.

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