Prin Regulatory Affairs Spec

Medtronic • Lafayette, CO

2d • 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 This position is located in Lafayette, CO as part of the Acute Care & Monitoring (ACM) group. The Principal Regulatory Affairs Specialist (Pr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the Bispectral Index™ (BIS™) monitoring product portfolio within the Acute Care and Monitoring operation unit. This role is fit for an established, productive individual contributor and leader who works independently on moderately to highly complex projects or programs with limited general supervision. In the position, you will set objectives for your own work to align with broader project goals and actively contribute to key milestones. You will also participate in cross-functional activities, requiring awareness of wider organizational issues. You will recommend and own improvements to systems and processes to enhance effectiveness and regularly communicate with internal stakeholders to share updates, gather input, and support decision-making. You will function as a subject matter expert within the organization and as an individually contributing leader. As such, you serve as a role model and may also guide entry-level professionals or support staff, eventually offering direction and assistance when needed. Responsibilities may include the following and other duties may be assigned.

Requirements

• Bachelor’s degree required
• Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.

Nice To Haves

• Experience in medical device regulatory
• Strong experience with class I and II electrical and software-based devices including applicable standards
• Strong knowledge of EU MDR, ISO 10993- 1, 13485, ans ISO risk management principles
• Experience with regulatory requirements for cybersecurity, AI, and communication devices (interoperability)
• Proven experience authoring and leading 510(k) submissions and EU Change Notifications
• Strong experience compiling MDR Technical Documentation.
• Experience communicating directly with regulators
• Collaborative, solution-oriented performer focused on bringing value to stakeholders and the organization
• Proven ability to develop and execute robust regulatory strategies
• Strong experience reviewing promotional materials for US/EU markets.

Responsibilities

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads and compiles all materials required for US and EU submissions and tenders, including 510(k) submissions, NB sampling, and EU MDR Technical Documentation.
• Supports submissions and inquiries for global markets.
• Collaborates closely with cross-functional partners such as R&D, clinical, operations, and marketing to establish regulatory value and ensure regulatory requirements and strategy are integrated into product development and lifecycle management.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Reviews promotional material.
• Monitors, updates, and improves project tracking and US/EU distribution control systems.
• Proactively monitor and interpret evolving global regulatory requirements and communicate potential impact to stakeholders.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible path to market.
• Support internal and external audits/inspections, including serving as a functional lead.
• Develop and deliver training on regulatory requirements and changes to cross-functional teams.
• Mentor junior regulatory staff or provide onboarding support.
• Participate in CAPA investigations when regulatory issues are identified.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• 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: Mid Level
• Number of Employees: 5,001-10,000 employees