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Principal Regulatory Affairs Specialist

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Regulatory Affairs
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2100016C Requisition #

Careers that Change Lives

 

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.

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.  

This is a cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.

Medtronic is a $30.6 Billion company with 90,000+ employees in more than 160 countries.

Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

 

The Principal Regulatory Affairs Specialist (Pr. RAS) is responsible for product regulatory strategies and submissions for the US and globally in partnership with geography-based Medtronic regulatory teams.  Develops strategies for worldwide governmental approval to introduce new products (Class III) to market and maintain existing products.  Provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval with the agencies.  Collaborates with R&D, Clinical, Quality, Marketing, Operations and other required functions to execute regulatory strategies from product inception, launch and throughout the product lifecycle.  

A Day in the Life
  •  Develop global regulatory strategies for medical devices to meet business objectives. 
  • Participate on Product Development teams, providing regulatory strategies, timelines, and direction.  Reviews and approves technical documentation.

  • Organize, prepare, and author complex high quality pre and post market submissions for global markets and work with Regional Business Units to obtain and maintain global product regulatory documentation, approvals and product renewals. 

  • Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle.

  • Assess impact of new and changing regulatory requirements, etc., as needed.

  • Drive product change assessments and define regulatory impact of product changes in global markets, in collaboration with regional regulatory partners. 

  • Review and approve labeling, training, promotional, and advertising material.

  • Maintain Regulatory Affairs regulatory product files and ensure compliance with regulatory requirements. 

  • Interpret and execute policies and procedures that comply with applicable global regulatory laws/standards and Company policies and procedures. Create departmental procedures.  

  • Participate on audit and field action teams as needed.

  • Maintain proficiency in U.S. regulatory requirements; establish and maintain good relationships with agency personnel.

  • Provide business and product information to international regulatory 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.

  • Travel up to 10%. (No travel during COVID-19 crisis)

Must Have (Minimum Requirements):
  • Bachelor’s Degree required with a minimum of 7 years of regulatory affaris experience in the medical device industry, or advanced degree with a minimum  of 5 years of regulatory affairs experience in the medical device industry.  

Nice to Have (Preferred Qualifications):
 
  • 7+ years of regulatory submission experience
  • Excellent writer
  • Advanced degree in a scientific discipline (engineering, physical/biological or health sciences)
  • Experience with PMA, IDE, De Novo, and/or 510(k) product and submissions.  PMA experience desired.  
  • Experience in supporting Class III device or IIb active medical device European Technical documentation and Submissions.
  • Highly proficient in spoken and written English.
  • Experience with negotiations/interactions with regulatory agencies/health authorities is preferred.
  • Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
  • Ability to effectively manage multiple projects and priorities 
  • Proven ability to lead and work effectively in cross-functional teams
  • Strong organization and time management skills
  • Demonstrated ability to influence based on experience, facts and data
  • Project-management skills and experience
  • Presentation skills for small to mid-sized groups
  • Submission-related word processing skills
  • Experience working within a medical device Quality System 

 

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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