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Senior Regulatory Affairs Specialist

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Regulatory Affairs
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21000H3R Requisition #

SENIOR REGULATORY AFFAIRS SPECIALIST

 

Medtronic’s Gastrointestinal (GI) Operating Unit offers state-of-art technologies to help with early detection and treatment of gastrointestinal and hepatology diseases/ cancers with focus on reducing complications through patient monitoring.

Careers That Change Lives  

The Senior Regulatory Affairs Specialist will be responsible for all regulatory activities pertaining to new product introduction and maintenance of existing products in global markets. This includes developing and exeucting regulatory strategies for product license renewals/amandments/new approvals, preparing product submission dossiers, and providing guidance to cross functional teams on global regulatory requirements. The position will work in close collaboration with regional/ in-country Medtronic RA teams and may also assist with the mentoring of other regulatory affairs specialists including providing work direction on projects of large scale with significant business impact.  

 

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

 

Location:  Sunnyvale, CA preferred; Open for Remote

 

A Day in the Life:

-  Prepare product submission dossiers in close collaboration with regional/ in-country Medtronic RA teams to ensure timely approvals for new products and changes to existing products.

- Work with cross functional teams (R&D technical experts, Clinical and Medical Affairs, Marketing, Sales, etc.)  to resolve potential issues and questions from regulatory agencies.

- Review significant submission decisions/content issues with 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 international agency personnel and business units.

- 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 international 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):
 
  • Bachelors degree required and 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):

  •  5+ years medical device industry experience
  • Experience with Class II/III medical devices including software (IEC 62304).
  • Experience with international regulatory agency requirements, harmonized IEC/ISO/ GHTF standards.
  • Experience with medical device global product registrations/ submissions: US FDA 510(k)s/ PMAs, EU Tech Files, Health Canada license applications, Shonin (Japan PMDA), China NMPA, APAC and Latin America submissions.
  • Medtronic product development experience
  • Clinical or statistical experience
  • Strong communication and project management skills
  • Effective interpersonal skills to be a good team member and mentor
  • 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 

 

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)

Abilty to travel up to 10%

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