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17 days old

Associate Regulatory Affairs Specialist

Medtronic
Sunnyvale, CA 94086
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Associate Regulatory Affairs Specialist

Location:

Santa Rosa, California, United States

Requisition #:

20000DUR

Post Date:

Sep 02, 2020


**ASSOCIATE REGULATORY AFFAIRS SPECIALIST**


**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.

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Posted: 2020-09-04 Expires: 2020-10-12
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Associate Regulatory Affairs Specialist

Medtronic
Sunnyvale, CA 94086

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