Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Location:

Plymouth, Minnesota, United States

Requisition #:

220005FJ

Post Date:

Mar 16, 2022

**Senior Regulatory Affairs Specialist - Surgical Innovations - Lung Health and Visualization**

The **Senior Regulatory Affairs Specialist** will collaborate with multiple cross-functional partners and with Medtronic international teams around the world to establish efficient strategies for implementing changes in the Lung Health product line. This product line includes complex software-driven technologies as well as biopsy tools used to diagnose abnormalities in the lung. The SeniorSpecialist will collate inputs from multiple functions, evaluate trade-offs, and make recommendations on how to best meet business objectives while maintaining global compliance. The work will include close collaboration with manufacturing, engineering, logistics, and RA teams based in Plymouth and around the world. Responsibilities include monitoring and analyzing the impacts of new or revised regulations or standards as well as the impacts of design and process changes. The Sr. Specialist will be involved with supporting international submissions as needed and may be responsible for assessing the impact of changes on regulatory status in the United States and European Union.

**Careers that Change Lives**

Corporate philanthropy is one way we work to increase our value to society. Our philanthropic efforts consisting of financial contributions (including funding of the Medtronic Foundation), product donations, volunteerism, and charitable third-party medical education improve healthcare and support communities where Medtronic employees live and give.

**A Day in the Life**

+ Communicate global regulatory impacts of various pending changes to operations and marketing to help establish priorities and timing of implementation

+ Make recommendations for the most efficient change implementation approach from the regulatory perspective

+ Collaborate with international RA teams to develop efficient global submission strategies that maximize product availability

+ Ensure that logistics controls are in place when needed to support the global change implementation strategy

+ Work with RA partners around the world to help them access and understand the documentation needed to support their regulatory submissions (new product launches, amendments, and renewals)

+ Manage multiple projects and prioritize tasks on a day by day basis to meet project schedules

+ Monitor changes in worldwide regulations and standards that affect the lung health product line and work with cross-functional partners to keep the product line at state of the art

+ Help maintain regulatory technical documents and communicate changes to our notified body as needed

+ Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities

+ Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements

+ Participate in internal and external audits as needed

+ Perform other duties as requested

**Must Have: Minimum Requirements**

+ Bachelors degree required with a minimum of 4 years of medical device regulatory affairs experience

+ OR an advanced degree with a minimum of 2 years of medical device regulatory affairs experience

**Nice to Have**

+ Degree in a scientific or engineering discipline

+ Prior experience working with international regulations or international regulatory teams

+ Prior experience with common medical device standards

+ Prior experience working with manufacturing and logistics

+ Working knowledge of systems such as SAP and other production planning tools

+ Solid interpersonal, analytical, writing, and organizational skills, including the ability to navigate the grey

+ Experience with FDA requirements, guidance documents, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other global regulatory requirements and quality standards

+ General understanding of product development process and design control through knowledge of US FDA and international medical device regulations

+ RAC credential preferred

**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.