Medtronic · 1 week ago
Regulatory Affairs Director
Lafayette, Colorado, United States of America
Full-time
Onsite
Director/Executive
$186K/yr - $280K/yr
10+ years expMedtronic is a leading global healthcare technology company dedicated to alleviating pain, restoring health, and extending life. They are seeking a Regulatory Affairs Director to lead regulatory strategy and manage a portfolio of high-impact medical devices while ensuring compliance and driving business success through effective team leadership and external engagement with regulatory bodies.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
Responsibilities
Develop and implement global regulatory strategies to support the entire product lifecycle, from R&D through to commercialization and post-market activities
Partner with R&D, clinical, operations, and marketing teams to ensure regulatory requirements are embedded into product development plans and timelines
Provide expert guidance on regulatory pathways, including expedited programs, for new product submissions (e.g., 510(k), etc.)
Lead and oversee the preparation, review, and submission of regulatory filings in the US and EU
Directly engage with regulatory bodies (e.g., FDA, Notified Body) to negotiate approvals and resolve complex regulatory issues
Direct the allocation of resources to a portfolio of product programs, ensuring alignment with corporate priorities and maximizing return on investment
Make key decisions on team structure, talent acquisition, and professional development to build a high-performing and scalable organization
Mentor and coach senior regulatory affairs managers to enhance their skills and foster future leaders
Serve as the senior-most authority on regulatory risk, identifying potential issues and developing mitigation strategies
Stay abreast of evolving regulatory trends, guidelines, and changes, providing proactive regulatory guidance
Serve as a key strategic advisor for major business initiatives and lead due diligence for regulatory risks and opportunities associated with new ventures and partnerships
Qualification
Required
Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred
Extensive experience in regulatory affairs (typically 10+ years)
Experience as a people manager managing large teams (typically 7+ years) within pharmaceuticals, biotechnology, medical devices, or related industries, preferably with some focus on external partnerships
Proven experience in a senior leadership role, with a track record of building and managing high-performing teams and departmental strategy
Deep and comprehensive knowledge of the global regulatory landscape and a proven history of successful interactions with regulatory bodies
Experience with advancing medical devices from concept to market approvals, post-market monitoring, and eventual discontinuation
Exceptional financial management skills, including strategic budget planning, and a strong understanding of business operations and corporate finance
Demonstrated expertise in driving large-scale, enterprise-wide process improvements and change management
Ability to leverage data and analytics to inform strategic decisions and communicate complex information to executive stakeholders
Superior communication, negotiation, and influencing skills, with the ability to operate at an executive level and represent the company externally
Preferred
Proven track record of successful regulatory leadership in managing external collaborations and partnerships
In-depth knowledge of global regulatory requirements and standards in the patient monitoring and respiratory spaces
Ability to travel domestically and internationally as required
Willingness to work outside of normal working hours to accommodate communication with global partners
Proficiency in regulatory software applications and databases
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)
Company
Medtronic
Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.
10001+ employees
H1B Sponsorship
Medtronic has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (349)
2024 (387)
2023 (291)
2022 (310)
2021 (300)
2020 (261)
Funding
Current Stage
Public CompanyTotal Funding
$18.16BKey Investors
NHS EnglandBlackstone Life SciencesTrade Capital Funding
2025-09-15Post Ipo Debt· $1.76B
2024-05-29Post Ipo Debt· $3.24B
2023-03-23Post Ipo Debt· $2B
Leadership Team
Geoffrey Martha
CEO and Chairman Of The Board Of Directors
Linnea Burman
SVP & President, Neurovascular
Recent News
BioWorld Financial Watch
2026-01-25
Company data provided by crunchbase