Regulatory Affairs Specialist - Cardiac Surgery

Medtronic • Mounds View, MN

1d • 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 The Cardiac Surgery Operating Unit is a highly specialized, multidisciplinary environment dedicated to the surgical treatment of complex heart and great vessel conditions. The unit brings together cardiac surgeons, anesthesiologists, perfusionists, nurses, and technologists who work in close coordination to deliver procedures such as coronary artery bypass grafting, valve repair and replacement, and advanced structural heart interventions. Equipped with state-of-the-art technology and supported by rigorous safety and quality protocols, the unit operates with a strong focus on precision, efficiency, and optimal patient outcomes. 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. The Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S. and global submissions, and obtaining and maintaining approval for CS products globally. Additionally, the Regulatory Affairs Specialist is responsible for assessing device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes.

Requirements

• Bachelor’s degree required with a minimum of 2 years of experience in regulatory affairs in the medical device industry Or an 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 for device submissions and interactions with regulatory agencies.
• 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 strong time management skills, with the ability to multitask, support multiple projects, prioritize, conduct team meetings, and meet project deadlines.
• Effective and respectful team member.
• Detail-oriented
• Ability to work independently with guidance from team.

Responsibilities

• Collaborate with Operating Unit Regulatory Affairs Specialists and regulatory affairs specialists globally to provide regulatory support for new products/therapies and changes to existing products.
• Actively work with cross-functional teams 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

• 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: Entry Level