Regulatory Affairs Specialist

Medtronic•Plymouth, MN

1d•$74,400 - $111,600•Hybrid

About The Position

The Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for products. Additionally, the Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes.

Requirements

Bachelor’s degree required
Minimum of 2 years of experience in regulatory affairs in the medical device industry Or advanced degree with a minimum of 0 years of experience in regulatory affairs in the medical device industry.
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 with Class II/III medical devices
Experience with regulatory support of clinical trials
Experience with FDA requirements, guidance documents, Medical Device Directive (MDD), Medical Device Regulation (MDR), and/or other global regulatory requirements and quality standards.
Effective negotiation and written/oral communication skills.
Effective interpersonal, organizational and time management skills.
Effective and respectful team member.
Detail-oriented

Responsibilities

Collaborate with Operating Unit Regulatory Affairs Specialists and international regulatory colleagues to provide regulatory support for new products/therapies and changes to existing products.
Work with engineers and technical experts to address questions from regulatory agencies.
Provide support to currently marketed products as necessary. This includes reviewing labeling, product or process changes as well as supportive documentation for changes requiring regulatory agency review.
Prepare submissions and reports for FDA or provide support and documentation for global submissions.
Maintain proficiency in worldwide regulatory requirements.
Obtain and distribute updated information regarding worldwide laws, guidelines, and standards.
Establish and maintain good relationships within the RA department, cross functional teams and assist in developing and maintaining positive relationships with device reviewers through oral and written communications.
Support regulatory compliance activities, including internal or external audits, post-market surveillance activities, etc. as needed.
Support product development programs as an extended core team member.
Assist in negotiations with the FDA or other regulatory agencies for assigned projects.
Other tasks, as assigned.

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)