Supports multiple banner ads per page, from any ad serving software. Flexible banner sizes
17 days old

Associate Regulatory Affairs Specialist

Sunnyvale, CA 94086
Apply Now
Applying for this job will take you to an external site
Associate Regulatory Affairs Specialist


Santa Rosa, California, United States

Requisition #:


Post Date:

Sep 02, 2020


**Careers That Change Lives**

The **Associate Regulatory Affairs Specialist** will assist with preparation of U.S. FDA submissions, Technical Files, reviewing design control documents and change requests, and being an active member of design teams representing the regulatory affairs responsibility. The Associate Regulatory Affairs Specialist may also be responsible for managing international regulatory registrations with the regional Business Units which includes global regulatory strategies and impact assessments, initial registrations, renewals and notifications/registrations of changes that may impact the regulatory approvals.

**A Day In The Life**

+ Establish and maintain a professional and credible image with the regulatory agencies.

+ Interface with clinical, regulatory, sales, marketing and administrative staff, as needed.

+ Assess product design, manufacturing, packaging, sterilization, and labeling changes for compliance with applicable regulations and prepare submissions, as required, by geography.

+ Prepare required submissions and reports for FDA and other global regulatory bodies.

+ Acts as liaison with Medtronic International regulatory personnel to address questions and issues that arise as part of the registration and/or testing process.

+ Provides status information to regulatory management as required

+ Ensure the timely and accurate filing of regulatory documentation.

+ Develop and maintain product technical files.

+ Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.

+ Participate in compliance activities that relate to the department and the company as a whole.

+ Perform other regulatory affairs duties when requested.

**Must Have; Minimum Requirements**

+ Bachelors Degree

+ 0 years of experience required

**Nice To Have**

+ Bachelors Degree in health profession, science and/or engineering field

+ Masters Degree in Regulatory Affairs

+ RAC Certification

+ Two or more years experience with regulatory affairs in the medical device industry

+ Demonstrated experience in preparing 510(k) submissions for FDA, experience with Class III devices are a plus

+ Demonstrated experience with submission to the European Union

+ Demonstrated technical writing 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.


Posted: 2020-09-04 Expires: 2020-10-12
Supports multiple banner ads per page, from any ad serving software. Flexible banner sizes

Job Rated Report

Resume Writing Advice

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Associate Regulatory Affairs Specialist

Sunnyvale, CA 94086

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast