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Senior Regulatory Affairs Specialist

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Senior Regulatory Affairs Specialist


Rice Creek, Minnesota, United States

Requisition #:


Post Date:

Mar 16, 2022


A career at Medtronic is like no other. Were purposeful. Were committed. And were driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.

Our vision is to become the undisputed world leader in Neuromodulation, improving patient lives through innovative solutions. Our therapiesspan the care continuum; from early interventional procedures to implantable surgical technologies that relieve pain, restore function and improve lives for our patients.

Be part of work that matters. 75 million patients had their health improved by our products last year. It is not just the products we make, each year we spend time in June volunteering, packing meals for groups, cleaning parks, painting fences.We give back. And with our paid volunteer time, you can too.

**Careers that Change Lives**

The **Senior Regulatory Affairs Specialist** is responsible for developing strategies for worldwide governmental approval to introduce new products (Class III) to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions, and negotiate their approval with the agencies.

This position will support worldwide regulatory activities associated with innovative drug delivery devices, including working with external pharmaceutical business partners. This position will also provide the potential to work on spinal cord stimulation products that address unmet needs for patients.

**A Day in the Life**

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

+ Team with business unit Regulatory Affairs Specialists and international regulatory staff 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, European, and Canada submissions as required to ensure timely approvals for market release. Review significant product submissions with manager and negotiate submission issues with agency personnel.

+ Provide support to currently marketed products. This includes reviewing labeling, engineering test reports, 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 the development of strategies and requirements and communicate that information to business teams.

+ Provide feedback and ongoing 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.

+ Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of the 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 the 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 the earliest possible approvals of clinical trials applications.

**Must Have: Minimum Requirements**

+ Bachelors degree

+ Minimum 4 years of experience in medical device regulatory affairs

+ ORminimum 2 years of experience in medical device regulatory affairs, and an advanced degree

+ Experience working with medical device or pharmaceutical regulatory submissions

**Nice to Have**

+ 7+ years medical device industry experience

+ Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and TUV), and working with cross-functional project teams

+ Experience with FDA requirements, guidance documents, Active Implantable Medical Device Directive, European Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards

+ Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).

+ Experience with Class II/III medical devices (510(k), PMA, IDE)

+ Experience with drug/device interaction test requirements/data

+ Experience with working with pharmaceutical companies

+ Experience with software development and cybersecurity applications

+ 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 performing advertising and promotion reviews for medical devices

+ Experience with FDA and international regulatory agency requirements, ISOIGHTF standards

+ Project management skills

+ Effective interpersonal skills

+ Effective team member

+ Clinical or statistical experience

+ Medtronic product development experience

**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)
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: 2022-03-18 Expires: 2022-05-27
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