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Senior Regulatory Affairs Specialist

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Regulatory Affairs
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210004PQ Requisition #

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident —we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.  This position will support our Defibrillation Solutions business within the Cardiac Rhythm Management (CRM) operating unit.

Careers That Change Live 

The Senior Regulatory Affairs Specialist will lead and develop strategies and submissions for U.S. and international product registrations.  They will partner with Medtronic Cross Functional members and Geography Regulatory Specialists to introduce Cardiac Rhythm Management (CRM) products to market. They will provide advice on regulatory requirements, prepare submissions and negotiate their approval.  The Senior Specialist also will lead process improvement efforts, mentor Regulatory colleagues and assist in the license maintenance including annual reports, renewals, design/manufacturing change notification, and QMS audits. 

 A Day In The Life

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

  • Provide regulatory support for currently marketed products.  This includes reviewing labeling and changes to existing devices and documentation.  Prepare submissions and reports for regulatory agencies as required.
  • Prepare U.S. and international submissions for new development products and device changes as required to ensure timely approval for market release.  
  • Review significant regulatory issues with supervisor, as necessary, and resolve submission issues with Medtronic engineering partners, Medtronic Geography Regulatory partners, and regulatory agencies as needed.
  • Prepare regulatory strategies/plans and compliance requirements.  Provide on-going support to project teams for regulatory issues and questions.  Find, interpret and apply regulations and guidance appropriately for situations.
  • Provide business and product information to enable development of strategies and requirements, as well as communicate that information to the Project teams.
  • Apply technical or regulatory principles, theories and concepts. 
  • Participate in project team meetings to plan strategies, including reviewing the various specifications and plans/reports, defining target market and distribution method, Medtronic requirements on testing, etc.
  • Work under general supervision following established procedures. Work independently to determine and develop approach.
  • Keep current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas.
  • Provide mentoring, training and support to other members of the department.
  • Other tasks, as required.

 

Must Have (Minimum Requirements):

  • Bachelor’s degree required with a minimum of 4 years of experience in regulatory affairs or the medical device industry, or advanced degree with a minimum of 2 years of experience in regulatory affairs or the medical device industry.

Nice To Have (Preferred Qualifications):

  • Master's in Regulatory Affairs
  • Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA, TUV), and working with cross-functional project teams.    
  • In depth experience with FDA requirements, guidance documents, Active Medical Device Directive/European Union Medical Device Regulations, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards 
  • Experience with Class II and III medical devices (510(k) and PMA)
  • History of successful device submissions and approvals
  • Strong negotiation skills and written/oral communication skills
  • Strong organizational skills and time management skills
  • Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
  • Ability to work independently and under general direction only 
  • Computer skills; MS Office, MS Project, Adobe Acrobat and Agile


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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