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27 days old

Senior Regulatory Affairs Specialist

Danvers, MA 01923
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Senior Regulatory Affairs Specialist


Danvers 35 Cherry Hill, Massachusetts, United States

Requisition #:


Post Date:

Aug 24, 2020


The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. This group includes Aortic and Peripheral Vascular, Cardiac Rhythm and Heart Failure, and Coronary and Structural Heart products.This position will support the innovative Transcatheter Valve Therapies business within the Coronary Structural Heart (CSH) business.

**Careers that Change Lives**

The **Senior 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. The Regulatory Affairs Specialist will provide support for regulatory activities including: technical writing to support regulatory submissions, product labeling and instructions for use creation.This role focuses on regulatory support for the US, EU, and Global markets, with a wide variety of regulatory tasks to allow you to make the most of your existing knowledge base while growing your RA skill set every day. In this role, you will have primary RA responsibility for multiple Class II and Class III products, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence.From developing and authoring regulatory submissions to providing critical input on cross-functional project teams, this role is an excellent opportunity for the right regulatory professional to take their career to the next level at the worlds leading medical device company.

**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.

+ 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.

**Must Have: Minimum Requirements**

+ Bachelors Degree in Science, Engineering, Healthcare, or related field

+ Minimum of 4 years of medical device regulatory experience, or advanced degree with a minimum of 2 years medical device regulatory experience

**Nice To Have**

+ Masters Degree in Regulatory Affairs

+ Experience with 510(k) submissions

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

+ Product Labeling requirements and standards

+ RAC certification

+ Product Labeling

+ Technical Writing

+ Systems Knowledge such as RA systems, content management systems

+ History of successful 510(k)/IDE/PMA device submissions and other worldwide submissions and clearances.

+ Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards

**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: 2020-08-27 Expires: 2020-10-04
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Danvers, MA 01923

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