Senior Regulatory Affairs Spec

Medtronic•Mounds View, MN

1d•$92,000 - $138,000•Hybrid

About The Position

Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. We are looking for a passionate Senior Regulatory Affairs Specialist in our Cardiac Ablation Solutions Operating Unit to work primarily on software-based medical devices. The candidate must have successful experience authoring and clearance of software submissions using FDA's eStar program as well as submissions to the EU Notified Body. A deep understanding of software engineering standard IEC 62304 and experience with software lifecycle process is also key. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This position will be based in Mounds View, MN. The Senior Regulatory Affairs Specialist develops strategies for worldwide product registration with global regulatory agencies to introduce Diagnostic products, Programmers and Programming Software and accessories for Pacemakers and Defibrillators, Patient Monitors, and Software as a Medical Device to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The specialist also assists with the license maintenance including renewals, design/manufacturing change notification, QMS audit, and Manufacturing site registrations.

Requirements

Bachelor’s degree in a technical discipline
Minimum 4 Years of medical device regulatory experience with Bachelor’s degree Or minimum 2 Years of medical device regulatory experience with an advanced degree
Must have successful experience authoring and clearance of software submissions using FDA's eStar program as well as submissions to the EU Notified Body.
A deep understanding of software engineering standard IEC 62304 and experience with software lifecycle process is also key.
Possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Nice To Haves

Master of Science Degree
Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and PMDA), and working with cross-functional project teams.
In depth experience with FDA requirements, FDA guidance documents, EU Medical Device Regulation, IEC 62304, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
Working knowledge of SaMD and SiMD
Positive track record engaging with regulators
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

Responsibilities

Prepare US and EU MDR submissions for new products and their product changes as required to ensure timely approval for market release.
Review significant regulatory issues with Manager, as necessary, and resolve submission issues with Medtronic engineering partners, Medtronic Geography Regulatory partners, and regulatory agencies as needed.
Prepare regulatory strategies/plans and worldwide 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 as necessary. 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.
Negotiate with international agencies, as needed. All significant issues will be reviewed with the supervisor.
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.