Sr. Regulatory Affairs Specialist - ACM

Medtronic • Mounds View, MN

1d • $92,000 - $138,000 • Hybrid

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 Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the Nellcor™ Blood Oxygenation Management Franchise within the Acute Care and Monitoring Operation unit. Activities include participation in change development projects, review and approve design control documentation, regulatory change assessments, author regulatory documents (MDR Technical Documents, STEDs or 510ks) and supporting EU MDR implementation. The Sr. RAS role translates regulatory requirements into project/product requirements and collaborates cross-functionally, while ensuring timely and high-quality execution of assigned regulatory deliverables. This position is most suited for individuals with a broad background covering the total regulatory life cycle of medical devices and strong working knowledge and experience with reviewing advertising and promotional materials for medical devices. The initial project scope for this employee will be related to regulatory sustaining activities. NPD activities may be tied into the role later on. Location: Strong preference to have candidates work hybrid from Boulder, CO or Minneapolis, MN. Remote within the U.S. may be considered for the right candidate.

Requirements

• Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
• May have practical knowledge of project management.
• Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Responsibilities

• Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering both domestic and international regulations
• Prepare 510(k) submissions and technical documents to support CE mark and other international submissions
• Prepare rationales to file documentation for modifications to devices when appropriate
• Participate in negotiations and interactions with regulatory authorities during the development and review process
• Provide business and product information to the international regulatory affairs team to enable development and strategies and requirements and communicate that information to the business team
• Support international product registrations as needed
• Manage multiple projects and prioritize tasks on day by day basis to meet project schedules
• Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities
• Review promotional and advertising material
• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards
• Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements
• Participate in internal and external audits as needed
• Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements
• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Perform other duties as assigned or 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, and 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees