1+ months

Senior Regulatory Affairs Specialist - Aortic Business Unit

Santa Rosa, CA 95404
Senior Regulatory Affairs Specialist - Aortic Business Unit


Santa Rosa, California, United States

Requisition #:


Post Date:

Jun 24, 2020


The Aortic Business unit is a part of the Aortic, Peripheral and Venous (APV) Business Unit which specializes in life saving technologies to treat the diseases of the Aorta such as Aneurysms, Aortic dissections and transections.

This position will reside in the Aortic organization and support our life saving Aortic stent graft therapies.

**Careers that Change Lives**

The **Senior Regulatory Affairs Specialist** is responsible for developing strategies for global approvals to introduce new aortic stent graft products (Class II III) to market, maintain existing products, provide advice on regulatory requirements, prepares worldwide submissions and negotiates their approval with global regulatory agencies. In addition, this position also assists with the training of junior regulatory affairs associates and provides work direction on projects of large scale with significant business impact.

This position will provide an opportunity to work on life saving aortic therapies and also involves cross-functional interactions with other functions and mentoring of junior team members within the regulatory function.

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

+ Prepare global regulatory submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release.

+ Provide support to currently-marketed products. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare required submissions and reports for FDA and other global regulatory bodies.

+ Interact with global regulatory agencies on most projects/products at reviewer level.

+ Support regulatory compliance activities, including manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc., as needed.

+ Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.

+ Provide feedback and on-going support to product development teams for regulatory issues and questions.

+ Work closely with cross functional team members in quality , clinical and RD as required on pre-market and postmarket projects to write submissions as well as resolve regulatory agency questions.

+ Mentor or supervise other RAS.

**Must Have: Minimum Requirements**

+ Bachelors degree

+ Minimum 4 years of experience in medical device

+ OR Minimum 2 years of experience in medical device and an advanced degree

**Nice To Have**

+ 5+ years medical device industry experience

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

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

+ Experience working with medical device or pharmaceutical regulatory submissions

+ Ability to effectively manage multiple projects and priorities.

+ Experience with Class II/III medical devices (510(k), PMA, IDE)

+ Experience performing advertising and promotion reviews for medical devices

+ Clinical or statistical experience

+ Experience with FDA and international regulatory agency requirements

+ Project management skills

+ Effective interpersonal skills

+ Effective team member

+ Proficiency in international medical device regulation e.g. China Regulations

**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: 2020-06-04 Expires: 2020-08-02

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Senior Regulatory Affairs Specialist - Aortic Business Unit

Santa Rosa, CA 95404

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