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Summary:
- 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.
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.
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.
- Effective and respectful team member who is detail oriented and capable of functioning on a global team.
- Experience working in a regulated, biotechnology environment with Class II/III medical devices and history of successful device submissions, interactions with regulatory agencies (e.g., FDA), and working with cross-functional project teams.
- Effective interpersonal, organizational and time management skills with experience in supporting multiple concurrent projects.
- Effective negotiation and written/oral communication skills with experience leading team meetings and working independently.
- Experience with FDA requirements, guidance documents, Medical Device Directive (MDD), Medical Device Regulation (MDR), and/or other global regulatory requirements and quality standards such as ISO 14971, ISO 13485 and IEC 60601.
- Experience with regulatory support of clinical trials.
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.
- Salary ranges for U.S (excl. PR) locations (USD): $77,600.00 – $116,400.00.
- This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
- 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).
- Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.
