Sr Regulatory Affairs Specialist

Medtronic • Lafayette, CO

4d • Onsite

About The Position

The Senior Regulatory Affairs Specialist will play a key role in supporting regulatory strategies and submissions for Robotics Surgery technologies in global markets. This role will contribute to new product development, as well as sustaining and lifecycle management activities for Class II medical devices that include hardware and software components. The Senior Regulatory Affairs Specialist will work closely with new product development and cross functional sustaining teams to help define global regulatory strategy and support regulatory activities throughout the product lifecycle, from concept and development through commercialization, post-market support, and product changes. This individual has primary responsibility for supporting compliance with U.S. and EU regulatory requirements and will partner with international regulatory affairs colleagues to support worldwide submissions for Class II medical devices. Responsibilities include supporting design changes, labeling updates, product modifications, and other lifecycle management activities to ensure ongoing regulatory compliance. Additional responsibilities include documenting regulatory decisions, preparing and supporting agency submissions, assessing regulatory impact of product and process changes, reviewing promotional materials, and ensuring product technical documentation remains current, accurate, and aligned with applicable regulatory requirements. This work is performed through collaboration with cross-functional partners across the business unit, including Regulatory Affairs, Research and Development, Clinical, Quality, Manufacturing, and Marketing. Additional responsibilities include keeping senior management informed of product regulatory status and significant regulatory issues, while maintaining strong knowledge of global regulatory requirements. The successful candidate will be comfortable working with advanced concepts and ambiguity, able to operate independently, develop creative regulatory strategies, and collaborate effectively within Regulatory Affairs and across other business functions.

Requirements

• Bachelor’s degree
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.

Nice To Haves

• Advanced degree in regulatory affairs, biomedical engineering, life sciences, or related field
• RAC certification or progress toward RAC certification
• Experience supporting Class II and Class III medical devices
• Working knowledge of global regulatory requirements, including FDA, EU MDR, Health Canada, and other international markets
• Experience preparing or supporting 510(k), PMA, Technical Documentation, or international submissions
• Familiarity with design controls, risk management, and usability engineering
• Understanding of software-enabled devices, cybersecurity, or AI-enabled products, if relevant to the portfolio
• Experience working with cross-functional teams including R&D, quality, clinical, marketing, and manufacturing
• Knowledge of applicable standards such as ISO 13485, ISO 14971, IEC 60601, and IEC 62304
• Experience with regulatory impact assessments for design changes, labeling updates, and product lifecycle management
• Strong technical writing, document review, and submission authoring skills
• Experience interacting with regulatory authorities, notified bodies, or internal auditors
• Project management skills with ability to manage multiple priorities and deadlines
• Strong communication and influence skills in a matrixed organization
• Experience with surgical, capital, or robotic medical devices.
• 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

• Provides regulatory strategy, submission support, and compliance oversight for surgical robotics medical devices across the product lifecycle.
• Recommends changes for labeling, manufacturing, software, cybersecurity, marketing, and design of medical devices for regulatory compliance.
• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company , internal audits and inspections.
• Leads or compiles all materials in submissions, license renewal and annual registrations.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.

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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior