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Senior Regulatory Affairs Specialist (Remote)

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Regulatory Affairs
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20000E0T Requisition #

SENIOR REGULATORY AFFAIRS SPECIALIST  (Remote)


The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions. SURGICAL INNOVATIONS sets the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.

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. Regulatory Affairs Specialist will provide support for regulatory activities including: technical writing to support regulatory submissions, product labeling and instructions for use creation.


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 and/or operations change control 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
  • Ensure relevant EU MDD requirements are met, as required
  • Review Change Orders and assess regulatory & labeling impact of product changes on US, MDD and/or International regulatory strategy and submissions per standard procedures
  • Excellent communication skills, strong documentation skills, Strong attention to details and technical Writing including authoring regulatory documentation, 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
  • Review Industry sites such as FDA, NBOG, RAPS, etc.
  • Other duties as assigned or required

Must Have: Minimum Requirements

  • Bachelor’s degree 
  • Minimum 4 years of medical device experience including knowledge of the US and International regulatory requirements
  • Or an advanced degree with minimum 2 years medical device experience including knowledge of the US and International regulatory requirements

 

Nice to Have

  • Bachelor’s degree in science, engineering or heath care related field
  • US and International medical device regulatory submission/approval experience, to include FDA and EU
  • Knowledge of FDA, EU MDD, MHLW, and TGA requirements
  • Experience of working with 510(k) and/or IDE and/or PMA devices
  • Medical Device Software experience
  • Product Labeling requirements and standards 
  • RAC certification or Certificate
  • IDE and/or PMA experience 
  • Product Labeling  
  • Technical Writing 
  • Systems Knowledge such as RA systems, Agile, SharePoint, Box or Quality Management Systems 


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.

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)

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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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