1+ months

Regulatory Affairs Specialist

Santa Rosa, CA 95404
Regulatory Affairs Specialist


Santa Rosa, California, United States

Requisition #:


Post Date:

Oct 16, 2019

**Careers that Change Lives**

The **Regulatory Affairs Specialist** is responsible for planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within the US and International Regions. Regulatory Affairs Specialist will provide support for regulatory activities including: technical writing to support regulatory submissions, product labeling and instructions for use creation.

**A Day in the Life**

+ Help with development of US and International regulatory strategies for product submissions.

+ Assist in keeping company informed of regulatory requirements in the US and International Regions

+ Participate on Product Development teams, providing regulatory labeling strategy, timelines, and direction

+ Support preparation of US and International submissions submissions.

+ Ensure relevant ISO and FDA Export requirements are met, as required

+ Review Change Orders and assess regulatory labeling impact of product changes on US and/or International regulatory strategy and submissions per standard procedures

+ Technical Writing: Authoring regulatory documentation including SOPs, product manuals, Instructions for Use (IFUs), process flows and work instructions.

+ Review labeling, training, promotional and advertising material

+ Comply with applicable FDA and international regulatory laws/standards and the Medtronic Code of Conduct

+ Other duties as assigned or required

**Must Have: Minimum Requirements**

+ Bachelors degree in science, engineering or heath care related field with

+ Minimum 2 years of Medical device experience including knowledge of the US and International regulatory requirements

+ Or Masters degree in Regulatory Affairs with 0-2 years experience

**Nice to Have**

+ US and International medical device regulatory submission/approval experience, to include FDA and EU

+ Knowledge of FDA, EU, MHLW, and TGA requirements

+ Experience of working with 510(k) and/or IDE and/or PMA devices

+ Product Labeling requirements and standards

+ RAC certification

+ IDE and/or PMA experience

+ Product Labeling

+ Technical Writing

+ Systems Knowledge such as RA systems, content management systems

**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: 2019-10-18 Expires: 2019-11-24

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Regulatory Affairs Specialist

Santa Rosa, CA 95404

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