Sr Regulatory Affairs Spec
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 At Medtronic, we are driven by our Mission to alleviate pain, restore health, and extend life for patients around the world. As part of the Robotics Surgical Technology business, you will help support innovative robotic-assisted surgical solutions that combine hardware, software, and clinical application to expand access to minimally invasive care. This role offers the opportunity to work in a highly collaborative, global environment where regulatory strategy directly supports product innovation, continued compliance, and patient access across international markets. The Sr. Regulatory Affairs Specialist will play a key role in planning, developing, and executing global regulatory strategies and submissions necessary to obtain and maintain regulatory approvals in international markets for Class II robotic medical devices. This role will partner closely with Geography Regulatory Affairs to support international submissions, government queries, registration documentation, product approval and clearance activities, product demand and release planning, and post-market regulatory compliance to help ensure continued product availability worldwide. The Sr. Regulatory Affairs Specialist will also represent the OUS regulatory function in sustaining and new product development projects by providing international regulatory requirements, assessing the impact of product changes, and shaping regulatory strategies that support both compliance and business objectives. This role will support EU MDR technical documentation maintenance, audit and inspection readiness, and global quality system compliance by ensuring regulatory documentation remains current, accurate, and aligned with applicable international requirements and internal procedures. The successful candidate will be a proactive, detail-oriented regulatory professional who can work independently, navigate complex global requirements, influence cross-functional partners, and help strengthen RA processes while supporting Medtronic’s Mission to improve patient access to life-changing therapies around the world.
Requirements
- Bachelor’s degree required
- Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.
Nice To Haves
- U.S. and international medical device regulatory submission experience, including FDA, EU, and global market pathways.
- Experience supporting Class II medical device approvals, registrations, renewals, and change notifications.
- Knowledge of international medical device regulations and standards, including US FDA, EU MDR, ISO 13485, and ISO 14971.
- Experience assessing regulatory impact of product, process, labeling, manufacturing, clinical, hardware, software, or design changes.
- Experience working with Geography RA partners, international regulatory teams, in-country affiliates, and cross-functional business partners.
- Strong technical writing, communication, analytical, organizational, and project management skills.
- Ability to work independently, manage multiple priorities, and influence in a global matrixed environment.
- 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.
Responsibilities
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
- Develops and executes global regulatory strategies for new or modified products for assigned projects.
- Leads or compiles all materials required in submissions, license renewal and annual registrations.
- Collaborate with business unit and geography regulatory affairs personnel to support marketing authorizations for assigned projects
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Participate and represent OUS regulatory function in sustaining and new product development projects to provide OUS regulatory requirements.
- Monitors and improves tracking / control systems.
- Keeps abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.
- Partners with R&D, Quality, Clinical, Manufacturing, and Regulatory teams to collect, review, and maintain technical documentation required to support global registrations, audits, and inspections.
- Supports the Regulatory Affairs function during internal audits, notified body audits and quality system inspections globally.
- Perform additional duties 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)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
