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Sr Regulatory Affairs Specialist


Mounds View, MN 55112
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Job Details

Sr Regulatory Affairs Specialist


Mounds View, Minnesota, United States

Requisition #:


Post Date:

Dec 03, 2020

**Senior Regulatory Affairs Specialist - Cardiac Surgery**

**_Careers that ChangeLives_**

The Senior Regulatory Affairs
Specialist is responsible for developing regulatory strategies, preparing U.S.
and international submissions and obtaining and maintaining approval for
products and therapies to markets worldwide.Additionally, the Senior Regulatory Affairs
Specialist is responsible for assessment of device changes for regulatory
implications and for performing regulatory activities in support of
implementing these device changes.

**A Day in the Life / Responsibilities:**

+ Definethe regulatory strategy and manage regulatory submission activities forcomplex product development activities and product maintenance forexisting approved products.

+ Team with business unitRegulatory Affairs Specialists (RAS) and international regulatory staffsto provide regulatory support for new products/therapies and changes toexisting products. Work with RAS,engineers and technical experts to resolve potential regulatory issues andquestions from regulatory agencies.

+ Prepare regulatory (e.g.,FDA/Notified Body) submissions for new products and product changes, asrequired, to ensure timely approvals for clinical studies and marketrelease. Review significant product submissions with manager and negotiatesubmission issues with agency personnel.

+ Provide support tocurrently marketed products as necessary. This includes reviewinglabeling, promotional material, product changes and documentation forchanges requiring government approval.

+ Interact directly withFDA/Notified Body and indirectly with international regulatory agencies onmost projects/products at reviewer level. All significant issues will bereviewed with the manager.

+ Support regulatorycompliance activities, including manufacturing site registration, audits, etc.,as needed.

+ Maintain proficiency inworldwide regulatory requirements; establish and maintain good relationshipswith agency personnel.

+ Provide business andproduct information to international regulatory staffs to enabledevelopment of strategies and requirements and communicate thatinformation to business teams.

+ Provide feedback andon-going support to product development teams for regulatory issues andquestions.

+ Ensurepersonal understanding of all quality policy/system items that are personallyapplicable.

+ Follow allwork/quality procedures to ensure quality system compliance and high-qualitywork.

**Must Have (Minimum Requirements):**

+ Bachelors degreerequired with a minimum of 4 years of experience in regulatory affairs in themedical device industry,or advanced degree with a minimum of 2 years ofexperience in regulatory affairs in the medical device industry.

**Nice to Have (Preferred Qualifications):**

+ 4+ years medical device industry experience.

+ Advanced degree in a scientific discipline (engineering,physical/biological or health sciences).

+ Effective interpersonal skills.

+ Effective team member.

+ Ability to comprehend principles of engineering, physiology andmedical device use. Good analytical thinking skills.

+ Ability to effectively manage multiple projects and priorities.

+ Proficient computer skills.

+ Experiencewith 510(k)/IDE/PMA device product submissions and other worldwidesubmissions and clearances.

+ Experience performing advertising and promotion reviews formedical devices.

+ Experience with FDA and international regulatory agencyrequirements

+ Project management skills.

+ Excellent oral and writtenskills.

+ Excellent analyticalthinking skills.

**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.
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