Medtronic Regulatory Affairs Specialist in Rice Creek, Minnesota
Regulatory Affairs Specialist
Rice Creek, Minnesota, United States
Nov 24, 2020
REGULATORY AFFAIRS SPECIALIST
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.
Careers That Change Live
The Regulatory Affairs Specialist develops strategies for worldwide product registration with Medtronic Geography Regulatory partners,and global regulatory agencies to introduce products and changes to market, provides advice on regulatory requirements, prepares submissions and negotiates their approval. The RA Specialist also assists with the license maintenance including annual reports, renewals, design/manufacturing change notification, QMS audit, and Manufacturing site registrations.
A Day In The Life
Prepare FDA, European and Canada submissions for product changes as required to ensure timely approval for market release. Review significant regulatory issues with supervisor, as necessary, and resolve submission issues with Medtronic engineering partners, Medtronic Geography Regulatory partners, and regulatory agencies as needed.
Prepare regulatory strategies/plans and compliance requirements. Provide on-going support to project teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations.
Provide business and product information to enable development of strategies and requirements, as well as communicate that information to the Project teams.
Provide regulatory support for currently marketed products. This includes reviewing labeling and changes to existing devices and documentation. Prepare submissions and reports for regulatory agencies as required.
Complete understanding and wide application of technical or regulatory principles, theories and concepts. General knowledge of other related disciplines.
Participate in the project team meeting to plan strategies, including reviewing the various specifications and plans/reports, defining target market and distribution method, Medtronic requirements on testing, etc.
Provide regulatory analysis of product portfolio and review with other functional resources, such as Marketing, Global Supply Chain, etc. Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
Work under general supervision following established procedures. Independently determines and develops approach.
Frequent inter-organizational contact and some external contacts.
Keeps current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas.
Provide training and support to other members of the department.
Other tasks, as required.
Must Have (Minimum Requirements):
- Bachelor’s degree in a technical discipline with a minimum 2 years of experience in regulatory affairs in the medical device industry, or advanced degree with 0 years of experience in regulatory affairs in the medical device industry
Nice To Have (Preferred Qualifications):
Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and BSI), and working with cross-functional project teams.
4+ years medical device industry experience
In depth experience with FDA requirements, guidance documents, Active Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
Experience with Class III medical devices (PMA)
History of successful device submissions
Strong negotiation skills and written/oral communication skills
Strong organizational skills and time management skills
Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
Ability to work independently and under general direction only
Computer skills; MS Office, MS Project, Adobe Acrobat and Agile
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)
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.
- Medtronic Jobs