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Associate Regulatory Affairs Specialist - Coronary and Structural Heart

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Regulatory Affairs
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19000JLL Requisition #

Associate Regulatory Affairs Specialist - Coronary and Structural Heart Products


The Associate Regulatory Affairs Specialist (ARAS) 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 world’s leading medical device company.

 


A Day in the Life  / Responsibilities:


• 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.

 

 

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.

 

Within CVG, Coronary and Structural Heart products include catheter based devices and other devices key to coronary procedures.

 

Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

 

Medtronic is a $29.7b company with 86,000+ employees in more than 150 countries.


Come for a job.  Stay for a career.

Must Have: Minimum Requirements
Education Required:
 
• Bachelor’s Degree
 
Years of Experience:
• 0+ years of medical device experience, with work experience in regulatory affairs with Bachelor’s degree.
 
 
Preferred experience:
• 3+ months of medical device experience, with work experience 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
 

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.
• The employee is required to be independently mobile
• The employee is required to interact with a computer, and communicate with co-workers

 
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.
 
Within CVG, Coronary and Structural Heart products include catheter based devices and other devices key to coronary procedures.
 
 
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. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Medtronic is a $29.7b company with 86,000+ employees in more than 150 countries.
 
Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.
 
 
EEO STATEMENT:
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.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
 
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