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Principal Regulatory Affairs Specialist- Structured Heart

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Regulatory Affairs
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18000G11 Requisition #
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PRINCIPAL REGULATORY AFFAIRS SPECIALIST - CORONARY & STRUCTURAL HEART


The Cardiac and Vascular Group (CVG) brings all of our cardiac and vascular businesses together into one 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. This group includes Aortic and Peripheral Vascular, Cardiac Rhythm and Heart Failure, and Coronary and Structural Heart products.

 

Careers that Change Lives

 

This position is part of the Structural Heart Regulatory Group and will support worldwide regulatory activities associated with the innovative transcatheter mitral valve therapy to treat mitral valve disease and provides a unique opportunity to shape the global regulatory strategy for a high risk class III implantable device from ground up. 


The Principal Regulatory Affairs Specialist will be responsible for developing strategies for worldwide governmental approval to introduce new products (Class III) to market, provide advice on regulatory requirements, prepare worldwide submissions and negotiates their approval with the agencies.  In addition, this position also assists with the mentoring of other regulatory affairs associates and provides work direction on projects of large scale with significant business impact. This position will provide an opportunity to work on innovative new product development project that seeks to address an unmet need for patients and also involves cross-functional interactions with other functions and mentoring of junior team members within the regulatory function.

 

A Day in the Life / Responsibilities:

  • Team with business unit Regulatory Affair Specialists and international regulatory staffs 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 FDA 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. Prepare submissions and reports for FDA and support other international agencies as required by product status.
  • Review only significant submission decisions/content issues with manager.
  • Interact directly with FDA and/or 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, GMP audit, post-market vigilance reporting, product recalls, 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 staffs 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.
  • May mentor or supervise other RAS, as directed by manager.

 

Must Have: Minimum Requirements 
  • Bachelor’s degree
  • 7+ years of experience in regulatory affairs or the medical device industry with Bachelor’s degree   OR
  • 5+ years of experience in regulatory affairs, or the medical device industry with engineering degree and Master's degree
  • Experience working with medical device or pharmaceutical regulatory submissions
 
Preferred experience:
  • 9+ years medical device industry experience
  • Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
  • Experience with Class II/III medical devices (510(k), PMA, IDE)
  • Experience performing advertising and promotion reviews for medical devices
  • Medtronic product development experience
  • Clinical or statistical experience
  • Experience with FDA and international regulatory agency requirements, ISOIGHTF standards
  • Effective interpersonal skills
  • Effective team member
  • Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
  • Ability to effectively manage multiple projects and priorities.
  • Proficient computer skills 
  • Project management skills
 
 
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.
• 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 by phone and in-person with peers and co-workers.
• Must be able to travel independently to various Medtronic buildings/sites or FDA locations.
• Must be able to travel by plane and by car.(<10%)
 

ABOUT MEDTRONIC:
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.
 
 
EEO STATEMENT:
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
 

DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
 
 
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