1+ months

Senior Regulatory Affairs Specialist

Santa Rosa, CA 95404
Senior Regulatory Affairs Specialist


Santa Rosa, California, United States

Requisition #:


Post Date:

Mar 26, 2021

**Careers that Change Lives**

The Structural Heart and Aortic integrated operating unit offers minimally-invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valvesaortic, pulmonic, mitral, tricuspidand the placement of stent grafts to treat aneurysms and dissections of the bodys largest artery, the aorta.

**Preferred Location: Santa Rosa, CA; Open for Remote**

**A Day in the Life**

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.

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

+ Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.

+ Leads or compiles all materials required in submissions, license renewal and annual registrations.

+ Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

+ Monitors and improves tracking / control systems.

+ Keeps abreast of regulatory procedures and changes.

+ May direct interaction with regulatory agencies on defined matters.

+ Recommends strategies for earliest possible approvals of clinical trials applications.

**Must Have (Minimum Requirements):**

+ Bachelors degree and a minimum 4 years of experience in medical device, OR Advanced degree with a minimum 2 years of experience in medical device.

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

+ 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: 2021-03-30 Expires: 2021-06-05

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Senior Regulatory Affairs Specialist

Santa Rosa, CA 95404

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