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Sr Regulatory Affairs Specialist -US CVG Peripheral Vascular

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Regulatory Affairs
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18000DRT Requisition #
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Senior Regulatory Affairs Specialist - US/EU - Aortic Peripheral Vascular
 
 
Medtronic’s Cardiac and Vascular Group (CVG) has an exciting opportunity for a Sr. Regulatory Affairs Specialist on the dynamic Peripheral Vascular (PV) RA team located in Plymouth, MN.
This role focuses on regulatory support for the US, EU, and Japanese 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.
 
Careers that Change Lives
 
The Senior Regulatory Affairs Specialist (Sr. RAS) develops and executes strategies for global regulatory approvals to introduce new and modified medical devices to the market for the APV business. The Sr. RAS translates regulatory requirements into project/product requirements, prepares regulatory submissions, and negotiates their approval with regulatory agencies as required.  Primary responsibilities include: developing global regulatory strategies; preparing US, EU and international regulatory submissions; providing documentation for international submissions; supporting post-market regulatory compliance activities; evaluating proposed product changes for regulatory impact, all while ensuring timely and high-quality execution of assigned regulatory deliverables. 

A Day in the Life  / Responsibilities:
 

 

• Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA and other worldwide government agencies. Able to write regulatory justifications to support submission filing decisions.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability.
• Interact with regulatory authorities during the development and review process to ensure submission approval.
• May be included as RA Representative on project teams with members of development project teams as necessary to communicate regulatory submissions requirements and preparations according to a defined timeline.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Review and approve ECN’s, PCN’s, NCR’s, product labeling and promotional materials, per company procedures, to assure compliance with regulatory requirements. 
• Maintain current knowledge of the development and changes to applicable laws, regulations and industry standards, and assist in the dissemination of this information to the appropriate individuals with the company. 
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams. 
• Recommends strategies for earliest possible approvals of clinical trial applications.

 

About CVG:
 
The Cardiac and Vascular Group brings all of Medtronic’s 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

 

Come for a job.  Stay for a career.

Must Have: Minimum Requirements
 
• Bachelor’s degree.
• 4+ years of medical device experience, with work experience in regulatory affairs with Bachelor’s degree.
• 2+ years of medical device experience, with work experience in regulatory affairs with Master’s degree.
• Experience in the preparation of 510(k) or PMA submissions for FDA and Technical Files for EU.

Preferred experience:
 
• Excellent analytical thinking skills
• Ability to effectively manage multiple projects and priorities
• Proven ability to lead and work effectively in cross-functional teams
• Excellent written and verbal communications skills
• Ability to work in matrix teams
• Strong organization and time management skills
• Demonstrated ability to influence based on experience, facts and data
• Highly motivated and results-oriented leader
• Project-management skills and experience
• Presentation skills for small to mid-sized groups
• Detail-oriented
• Ability to be flexible with changing priorities
• Submission-related word processing skills
• Knowledge of Quality System requirements and FDA and/or International product approval process. 
 
 
 
Cardiac and Vascular Group (CVG):
 
The Cardiac and Vascular Group brings all of Medtronic’s 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
The CVG group includes Aortic and Peripheral Vascular, Cardiac Rhythm and Heart Failure, and Coronary and Structural Heart products. Aortic Vascular Products include Chronic Total Occlusion Devices, Directional Atherectomy Systems, Drug-Coated Balloons, Embolic Protection Devices, Guidewires, Infusion Therapy Products, Peripheral and Biliary Stents, PTA Balloons, Snares, Support Catheters
 
ABOUT MEDTRONIC:

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.

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
 
 
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
 
 
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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