🌎
This job posting isn't available in all website languages

Principal Regulatory Affairs Specialist

📁
Regulatory Affairs
📅
21000E3H Requisition #
Careers that Change Lives

The Structural Heart and Aortic integrated operating unit offers minimally-invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves—aortic, pulmonic, mitral, tricuspid—and the placement of stent grafts to treat aneurysms and dissections of the body’s largest artery, the aorta.
 

The Principal Regulatory Affairs Specialist is responsible for developing strategies for worldwide governmental approval to introduce new products (Class II & III) to market, maintain existing products, provide advice on regulatory requirements, prepares worldwide submissions and negotiates their approval with the agencies.  In addition, this position also assists with the training of other regulatory affairs associates and provides work direction on projects of large scale with significant business impact.

 This position will support worldwide regulatory activities associated with Aortic products and therapies. 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.

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.

 To learn more about Inclusion & Diversity at Medtronic  Click Here

 

Preferred Location:  Santa Rosa, CA;  Open for Remote

 

A Day in the Life

  • 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 and a minimum 7 years experience in regulatory affairs or the medical device industry, OR advanced degree and a minimum of 5 years of experience in regulatory affairs, or the medical device industry.

 

Nice To Have (Preferred Qualifications):

  • Degree in engineering
  • 9+ years medical device industry experience
  • Experience working with medical device or pharmaceutical regulatory submissions
  • Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
  • 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 
  • 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
  • Project management 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)

My Profile

Create and manage profiles for future opportunities.

Go to Profile

My Submissions

Track your opportunities.

My Submissions

Similar Listings

Santa Rosa, California, United States

📁 Regulatory Affairs

Requisition #: 21000KOR

Santa Rosa, California, United States

📁 Regulatory Affairs

Requisition #: 21000JX4

Santa Rosa, California, United States

📁 Regulatory Affairs

Requisition #: 21000JMY

FORTUNE NAMES MEDTRONIC TO 'CHANGE THE WORLD' LIST

FORTUNE puts Medtronic among the top 20 companies worldwide having a positive social impact through core business strategy.

Read The Story

ENGINEERING

Bring your talents to help us build life-changing technology

LEARN MORE

Three Women Working

INCLUSION AND DIVERSITY

We believe that when people from different cultures, genders, and points of view come together, innovation is the result — and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

SEE HOW