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Senior Regulatory Affairs Specialist

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Regulatory Affairs
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20000IU7 Requisition #

SENIOR REGULATORY AFFAIRS SPECIALIST

The Cardiovascular portfolio delivers market leading technologies across the entire spectrum of cardiac and vascular care. The Structural Heart team develops and creates interventional devices and therapies to treat structural defects of the heart. This role will support transcatheter heart valve products within the Structural Heart team.

Career That Change Lives

The Senior Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for products and therapies to markets worldwide. Additionally, the Senior Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes. 

A Day In The Life

  • Define the regulatory strategy and manage regulatory submission activities for complex new product development activities and product maintenance for existing approved products.
  • Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory affairs staff to provide regulatory support for new products/therapies and changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
  • Prepare regulatory submissions for new products and product changes, as required, to ensure timely approvals for clinical studies and market release. Review significant product submissions with manager and negotiate submission issues with agency personnel.
  • Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. 
  • Interact directly with FDA and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.
  • Support regulatory compliance activities, including manufacturing site registration, audits, etc., as needed.
  • Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
  • Provide business and product information to international regulatory affairs staff to enable development of strategies and requirements and communicate that information to business teams. 
  • Provide feedback and on-going support to product development teams for regulatory issues and questions.
  • Ensure personal understanding of all quality policy/system items that are personally applicable.  
  • Follow all work/quality procedures to ensure quality system compliance and high-quality work.

 

Must Have; Minimum Requirements

  • Bachelor's Degree 
  • Minimum of 4 years of regulatory experience or an advanced degree with a minimum of 2 years of regulatory experience.

Nice to Have

  • 4+ year medical device industry experience
  • Degree in a scientific discipline (engineering, physical/biological or health sciences).
  • Advanced degree - Regulatory Affairs
  • Experience with Class III medical devices.
  • History of successful 510(k)/IDE/PMA device product 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 
  • Experience working with cross-functional teams.
  • Experience working with technical documentation.
  • Ability to comprehend principles of engineering, physiology, and medical device use. 
  • Ability to effectively manage multiple projects and priorities.
  • Strong organizational skills and time management skills 
  • Excellent oral and written skills
  • Excellent analytical thinking skills
  • Effective team member
  • Proficient computer skills
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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Challenge 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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