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1+ months

Senior Regulatory Affairs Specialist

Rockwood, TN 37854
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Senior Regulatory Affairs Specialist


Yokneam, Industrial Zone, HaTsafon, Israel

Requisition #:


Post Date:

Jul 28, 2020

Careers That Change Lives:

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

As a Senior Regulatory Affairs Specialist you will be 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. You will prepare worldwide submissions and negotiate 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.

A Day in the Life:

+ 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.

**Must Have:**

+ Bachelors degree

+ Minimum 4 years of experience in regulatory affairs or the medical device industry OR minimum 2 years of experience in regulatory affairs in the medical device industry with advanced degree

**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)

At Medtronic, you will find a diverse team of innovators who bring their unique backgrounds and their individual life experiences to work every day. We work hard to cultivate a workforce that reflects our patients and partners, we believe its the only way to drive healthcare forward. We want to attract a diverse workforce, regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, veteran status, or any other characteristic protected by state or local law. Join us and bring the power of your point of view to our culture of collaboration and innovation. It is through strong diversity, inclusion and engagement that we can remain a leader in medical technology and solutions. And by embracing everything you have to offer your unique perspectives, talents and contributions we can live up to the promise of our Mission
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: 2020-07-30 Expires: 2020-10-05
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