Senior Regulatory Affairs Specialist

Medtronic•Mounds View, MN

18h•Onsite

About The Position

The Cardiac Rhythm Management (CRM) operating group at Medtronic is seeking a Senior Regulatory Affairs Specialist. This division focuses on developing and manufacturing medical devices and solutions for cardiac arrhythmias and heart failure, including implantable pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, and remote monitoring systems. The group'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. Medtronic emphasizes in-person collaboration, requiring a minimum of 4 days a week onsite at their Mounds View, MN location, to foster professional growth and cross-functional collaboration. The Senior Regulatory Affairs Specialist will be responsible for developing 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. This role involves providing advice on regulatory requirements, preparing worldwide submissions, negotiating their approval, and assisting with 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
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.

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

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. 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., 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

Competitive Salary
Flexible Benefits Package
Incentive plans (Medtronic Incentive Plan - MIP)
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)
Health, Dental and vision insurance (for regular employees who work 20+ hours per week)
Health Savings Account (for regular employees who work 20+ hours per week)
Healthcare Flexible Spending Account (for regular employees who work 20+ hours per week)
Life insurance (for regular employees who work 20+ hours per week)
Long-term disability leave (for regular employees who work 20+ hours per week)
Dependent daycare spending account (for regular employees who work 20+ hours per week)
Tuition assistance/reimbursement (for regular employees who work 20+ hours per week)
Simple Steps (global well-being program) (for regular employees who work 20+ hours per week)
Paid sick time (for temporary employees, as required under applicable state law)