Senior Regulatory Affairs Specialist

Medtronic•Mounds View, MN

1d•$92,000 - $138,000•Onsite

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life The Cardiac Rhythm Management operating group is a division within Medtronic focused on developing and manufacturing medical devices and solutions for the management of cardiac arrhythmias and heart failure. This group’s product portfolio includes implantable pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, and remote monitoring systems. CRM’s mission is to improve patient outcomes and quality of life by providing innovative therapies for the detection, prevention, and treatment of abnormal heart rhythms. The group collaborates closely with healthcare professionals and leverages advanced technology and data-driven insights to drive improvements in cardiac care. 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

Nice To Haves

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.
Master of Science Degree
In depth experience with FDA requirements, guidance documents, Medical Device Directive, 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
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Responsibilities

Prepare worldwide submissions for new products and their 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 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.
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., to ensure Diagnostics and EPG portfolio is aligned with existing portfolio.
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.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)