Senior Regulatory Affairs Specialist

Medtronic•Mounds View, MN

6h•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 In Coronary and Renal Denervation, we love what we do. That's because we're passionate about the patients we serve around the globe and the "second life" and improved health we can give to those with Coronary Artery Disease, High Blood Pressure, and other conditions. We're also driven by the promise of Renal Denervation and its potential to change the way patients around the world manage their uncontrolled hypertension. 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 or Santa Rosa, CA. The Senior Regulatory Affairs Specialist will support Research and Development programs with pre-market regulatory strategy development for worldwide product registration with global regulatory agencies to introduce Coronary & Renal Denervation devices to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. This will include expertise in regulatory software development strategies (SaMD, AI, Machine Learning, Cybersecurity, etc.,) to support the operating units’ (OU’s) innovative pipeline. The specialist will work in collaboration with Regulatory Affairs Team members, cross functional members at varying levels within the organization as well as International Regulatory Affairs staff, supporting US and international submissions, change management assessments, the review and approval of advertising and promotional materials for commercial products across the CRDN portfolio and QMS audits as needed.

Requirements

Bachelor’s degree in a technical discipline
4+ years of medical device regulatory experience OR 2+ years of medical device regulatory experience with an advanced degree

Nice To Haves

Experience working in regulated environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA, Notified Bodies, NMPA and PMDA etc.), and working with cross-functional project teams
Master of Science Degree
In depth experience with FDA requirements, guidance documents, Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
Experience working with cross functional PDP teams
Direct Regulatory Affairs experience supporting programs throughout software development life cycle
Direct experience authoring and successful approval of regulatory submissions for Class IIb /III/IV medical devices in the US, Japan, or EU (e.g., IDE, PMA, CTN, Shonin, Technical Documentation)
Direct experience supporting successful software device development (SaMD, AI, Cybersecurity, IEC 62304/82304) and associated regulatory filings in the U.S., EU, and globally
Experience with negotiations/interactions with regulatory agencies/health authorities
Experience performing advertising and promotion reviews/approvals for medical devices
Computer skills: MS Office, MS Project, Adobe Acrobat and Agile

Responsibilities

Act as a team member on development projects to provide regulatory guidance and develop global regulatory strategies and timelines for key markets.
Author and prepare regulatory 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 cross functional partners, Medtronic Geography Regulatory partners, and regulatory agencies as needed.
Prepare regulatory strategies/plans taking inputs and incorporating worldwide compliance requirements.
Provide on-going support to product development 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 product development 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 regulatory 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.
Work under general supervision following established procedures.
Independently determines and develops approach.
Keep current on global directives, regulations harmonized standards and Medtronic procedures and communicate changes that may affect cross functional areas.
Provide mentorship, training and support to other junior members of the department.
Provide regulatory review and guidance for proposed product claims/labeling and advertising and promotional materials.
Participate in inspections/audits either performed internally, by notified bodies, or by other international regulatory bodies.
Assist regulatory department in the update, enhancement, and creation of internal policies and procedures.
Support assessment and recommendation of new and changing regulations, guidance documents, requirements as needed
Other tasks, as required.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values.
We recognize their contributions.
They share in the success they help to create.
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).