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Sr Regulatory Affairs Specialist - Globalization

Sunnyvale, CA 94086
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Sr Regulatory Affairs Specialist - Globalization


Sunnyvale, California, United States

Requisition #:


Post Date:

Dec 14, 2020


**Sunnyvale, CA or Boulder, CO**

Careers That Change Lives

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

Our Gastrointestinal and Hepatology (GI) business offers technologies to help with early detection and treatment of gastrointestinal diseases and cancers, and focuses on reducing complications through patient monitoring.

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.

A Day in the Life / Responsibilities:

- Team with business unit Regulatory Affair Specialists (RAS) 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 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 work on submission with regional counterparts.

- 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 international agencies as required by product status.

- Interact directly and/or indirectly with international regulatory agencies on most projects/products at reviewer level. 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.

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

Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.

Leads or compiles all materials required in submissions, license renewal and annual registrations.

Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

Monitors and improves tracking / control systems.

Keeps abreast of regulatory procedures and changes.

May direct interaction with regulatory agencies on defined matters.

Recommends strategies for earliest possible approvals of clinical trials applications.

Must Have: Minimum Requirements

Bachelors degree with 4+ years of experience in regulatory affairs and/or the medical device industry OR Advanced degree with 2+ years of experience in regulatory affairs and/or the medical device industry

Nice To Have:

5+ years medical device industry experience

Experience with Class II/III medical devices

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.

Experience performing advertising and promotion reviews for medical devices

Medtronic product development experience

Clinical or statistical experience

Experience with international regulatory agency requirements, harmonized IEC/ISO/ GHTF standards.

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. Lets 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)

Travel up to 25%
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.


Posted: 2020-12-24 Expires: 2021-02-22
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Sunnyvale, CA 94086

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