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Regulatory Affairs Specialist

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Regulatory Affairs
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19000DU6 Requisition #
Careers that Change Lives


Responsible for preparing and supporting regulatory submissions to obtain and maintain product approvals worldwide assuring compliance with Medtronic, FDA and international requirements.


A Day in the Life


Responsibilities may include the following and other duties may be assigned.

  • Assist in worldwide product approval submissions.
  • Provide regulatory support for market-released products as necessary. This includes reviewing product/manufacturing process changes for regulatory impact and documentation for changes requiring government approval. Assist in the preparation of periodic reports for FDA and other major market regulatory agencies as required by product status. Submission decision/content will be approved by manager.
  • Provide Medtronic personnel with advice on U.S. and foreign regulatory issues or requirements.
  • Maintain Regulatory documentation.
  • Assists in facility inspections by regulatory agencies.
  • May assist in maintenance of regulatory registrations worldwide.
  • Perform other related tasks as required


Must Have: Minimum Requirements
  • Bachelors degree required
  • Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience


Additional Requirements

  • Bachelor’s Degree in technical/scientific field and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
  • Previous experience in Regulatory Affairs or Quality Assurance with a medical device manufacturer.
  • Demonstrate ability to work on cross functional teams.
  • Knowledge of GMP/FDA regulations
  • Some Knowledge of the Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directives and upcoming Medical Device Regulations, and the current ISO 13485 and JPAL
  • Excellent PC skills, including word processing, spreadsheets.
  • Excellent organizational and judgment skills.
  • Ability to maintain and generate accurate records.
  • Strong written, verbal and interpersonal skills
  • Ability to comprehend basic principles of engineering, physiology and medical device use
  • Some skill in the use of ERP systems such as SAP
  • Experience with cardiovascular devices and knowledge of QSR and ISO-13485 system requirements
  • Clinical knowledge of medical devices
  • Knowledge of Statistics


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 here 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 sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel objects, tools, or controls. The employee is occasionally required to stand, walk, lift, and reach with hands and arms. Specific vision abilities required by this job include normal vision.


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Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.

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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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