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Sr Regulatory Affairs Specialist

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Regulatory Affairs
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1900050J Requisition #
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Senior Regulatory Affairs Specialist - Medtronic Navigation 

 

 

The Senior Regulatory Affairs Specialist will develop strategies for worldwide regulatory approval to introduce new products to market, preparing U.S. submissions and negotiating their approval.  In this role, you will negotiate with regulatory agencies on complex submissions issues.


Careers that Change Lives

 


A Day in the Life  / Responsibilities:

 

  • Follow all Quality System Practices and SOP’s as defined by Medtronic MNav policies, practices and procedures to ensure that FDA’s Quality System Regulation, ISO 13485, MDD, MHLW, CMDR and all other applicable regulations are met.
  • Maintain current knowledge of the developments and changes to applicable laws, regulations and industry standards, and assist in the dissemination of this information to the appropriate individuals with the company and sector.  Interpret new and existing regulatory requirements as they relate to the products and initiate actions to assure compliance to these regulations.
  • Provide guidance and direction to ensure FDA and international product registration/licensing requirements are addressed and met prior to commercial release.
  • Perform submission activities for devices in gaining required clearances through the processes of IDE’s, 510(k)s, PMA’s, CE marking and other world-wide approval requirements as necessary.
  • Perform new and on-going reviews of marketing materials, go-to-market strategies and other commercialization activities as required to insure continued compliance to established product clearances; lead the development of regulatory strategies for new claims, indications and therapies.
  • Provide support to market-released products as necessary. This includes reviewing labeling, promotional material, product/manufacturing process changes and documentation for changes requiring regulatory approval. Prepare submissions and reports for FDA and support other international agencies as required by product status.
  • Work with other departments to support CAPA investigations, root cause determinations, situation analyses, risk evaluations and regulatory assessments.
  • Manage field corrective action plans and associated regulatory body notifications.
  • Provide regulatory support for external audits performed on Medtronic Navigation quality systems
  • Approve accept with concessions dispositions for nonconforming product based on product and regulation knowledge as well as critical thinking. 
  • Perform all activities in compliance with the Quality System.
  • Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
  • All other duties as assigned. 

 


Come for a job.  Stay for a career.

Must Have: Minimum Requirements
 
• Bachelor’s degree.
• 4+ years medical device industry experience in applicable domestic / International submissions, design control systems and/or regulatory compliance.
• 3+ years experience with medical device regulatory submissions.
• Experience with FDA, ISO, QSR, or EU regulations for handling complaints, reporting incidents, and implementing corrective and preventive actions.

Preferred experience:
 
• Experience in due-diligence evaluations of companies and/or product acquisitions.
• Experience in marketing materials review and the maintenance of compliant commercialization strategies.
• Experience in electromedical devices.
• Experience with biocompatibility testing and sterilization validation preferred.
• Experience with international medical device consensus standards preferred.
• Good presentation skills.
• Excellent oral and written communication skills.
• Must be able to handle multiple tasks/projects and manage priorities accordingly.
• Have a high tolerance for ambiguity.
• Ability to work in a team environment and exert influence without alienating others.
• Ability to work independently when required with minimal management oversight.
• Under general supervision, works within established guidelines and has flexibility as to method, priority and timing of job duties. This position requires a significant amount of initiative and judgment.
 
 
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.
• 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.
• Must be able to travel independently to various Medtronic buildings/sites.
• Must be able to travel by plane and by car.(<10%)
 

RTG (Restorative Therapies Group) Overview

The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
 
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

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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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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