Prin Regulatory Affairs Spec

Medtronic•Mounds View, MN

2d•$120,000 - $180,000•Onsite

About The Position

The Principal Regulatory Affairs Specialist will play a key role in launching new products and sustaining the Wound Management product portfolio. As a new product development (NPD) core team member, the principal specialist works directly with the NPD team from the opportunity phase through commercialization. The principal specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide for Wound Management devices. Sustaining regulatory responsibilities include reviewing product labeling changes to ensure that regulatory requirements continue to be met, documenting “no file” decisions, reviewing promotional materials, and ensuring that our product technical documentation is current and accurate. 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.

Requirements

Bachelor’s degree required
Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
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.
The employee is also required to interact with a computer, and communicate with peers and co-workers.

Nice To Haves

Experience successfully achieving FDA clearance through a 510(k) submission
Experience interacting directly with the FDA
Experience managing or contributing to multiple regulatory submissions
Familiarity with medical device regulatory lifecycle management.

Responsibilities

Provide regulatory affairs domain expertise and influence at all levels in support of the Wound Management device portfolio
Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering both domestic and international regulations
Prepare Pre-Sub and 510(k) submissions and technical documents to support CE mark and other international submissions
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
Collaborated with engineering, quality, clinical, marketing, and other functions 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
Maintain regulatory affairs documentation to support compliance with applicable regulatory requirements
Perform other duties as assigned or required.

Benefits

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)