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Senior Regulatory Affairs Director

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Senior Regulatory Affairs Director


Plymouth, Minnesota, United States

Requisition #:


Post Date:

Oct 20, 2021

**Careers that Change Lives**

The Senior Director of Regulatory Affairs will report directly to the VP of Regulatory Affairs, PVH.This position overseesa team withresponsibility for gaining and maintaining approvals for a wide range of products within the Peripheral Vascular Health (PVH) portfolio. This person partners with cross-functional colleagues to ensure RA activities are aligned with business priorities. They develop and maintain strong working relationships with colleagues across the regions to manage global approvals. This person must be adept at managing regulatory agency relationships. They must be a natural coach with a wide range of regulatory experience.

**A Day in the Life**

Responsibilities may include the following and other duties may be assigned.

+ Manage a team of Regulatory Affairs professionals at varying levels of experience

+ Coach staff on defining efficient global approval strategies in line PVH objectives

+ Along with direct management staff, set and uphold high standards of compliance across the spectrum of Regulatory Affairs activities

+ Act as Regulatory Affairs business partner to cross-functional colleagues

+ Engage in enterprise-wide Regulatory Affairs and cross-functional teams as the voice of PVH

+ In collaboration with PVH RA staff, develop and maintain department procedures and systems, with a focus on continuous improvement

+ Participate in the PVH strategic planning process

+ Maintain effective relationships with corporate and regional Regulatory Affairs teams

+ Develop and maintain strong relationships with FDA and notified body staff

+ Attract, hire, and develop talent to align with PVH needs

+ Actively participate in internal and external inspections including partnering in responding to observations, defining, and implementing corrective actions

+ Participate in root cause analysis/failure investigations when necessary


**Must Have: Minimum Requirements**

+ Bachelors degree

+ Minimum of 15 years of relevant regulatory affairs experience with 10+ years of managerial experience , or Advanced Degree with a minimum 13 years prior relevant regulatory affairs experience, minimum of 10 years of managerial experience

+ Must be able to travel domestically and internationally up to 30% of the time

**Nice to Have: Preferred Requirements**

+ 10 +years of direct management experience

+ Advanced degree

+ Class III PMA cardiovascular device experience

+ Combination device experience

+ Regulatory Affairs Certification (RAC)

+ Experience working with Clinical data

**About Medtronic**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


Posted: 2021-10-22 Expires: 2021-12-31
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