Director, Regulatory Affairs Operations
- Location
- Lafayette, Colorado, United States of America
- Work mode
- On-site
- Employment type
- Full-time
About the job
We anticipate the application window for this opening will close on - 14 Nov 2026
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life The Director of Regulatory Affairs Operations is a member of the ACM Regulatory Affairs Leadership Team and leads the multidisciplinary capabilities that create the operating backbone for consistent, scalable, and compliant regulatory execution. This role is accountable for traditional regulatory affairs operations as well as specialty activities including radiofrequency registrations, OEM market access and broader business development regulatory work, portfolio phase outs, and regulatory compliance programs. The Director translates business priorities into operating plans and disciplined execution while leading approximately seven direct reports and influencing broadly across a global matrixed organization.
Responsibilities may include the following and other duties may be assigned.
Regulatory Operations & Transformation
- Create and execute the RA Operations strategy, operating model, and roadmap aligned with ACM and enterprise Regulatory Affairs priorities.
- Own and continuously improve the systems, processes, data governance, tools, and workflows that enable regulatory execution across the product lifecycle, including regulatory information management, product lifecycle management, dashboards, and planning tools.
- Lead simplification, standardization, automation, artificial intelligence enablement, and scalable service delivery initiatives that improve speed, quality, compliance, and organizational capacity.
- Assess complex operational risks and bottlenecks, set priorities, make timely decisions, and drive sustainable solutions actions across the function.
Radiofrequency Regulatory Leadership
- Provide strategic and operational leadership for radiofrequency regulatory requirements that support global market access for connected and wireless ACM products.
- Establish and mature ACM radiofrequency governance and quality system processes, embedding requirements, testing strategies, and registration planning early in product development and lifecycle activities.
- Oversee external testing laboratories, registration partners, and other third parties to ensure quality, timeliness, cost effectiveness, and compliance.
- Partner with engineering, product development, quality, regional regulatory teams, and enterprise experts to resolve complex radiofrequency issues and scale execution across the portfolio.
OEM and Business Development Regulatory Leadership
- Lead end-to-end regulatory stewardship for OEM devices, including deal assessment, agreement content, registration planning and execution, product release readiness, and ongoing lifecycle obligations.
- Serve as the regulatory lead for broader BD&L activities, including due diligence, risk assessment, integration planning, transition of regulatory ownership, and handoff to steady-state teams.
- Build effective regulatory-to-regulatory relationships with external partners and establish clear governance, deliverables, escalation pathways, and performance expectations.
- Identify regulatory risks, obligations, and value-creation opportunities early enough to influence deal structure, investment decisions, integration plans, and market access commitments.
Regulatory Compliance & Governance
- Lead regulatory compliance programs and governance across ACM RA, including regulatory intelligence, standards transitions, audit readiness, quality system procedures, and compliance monitoring.
- Provide oversight and coordination for regulatory actions and signals, including field action-related regulatory support, CAPAs, health hazard assessments, inspection observations, and other compliance commitments, in partnership with Quality and business leaders.
- Translate evolving global requirements into clear business impact, accountable implementation plans, and timely closure of commitments.
- Escalate significant compliance risks with clear options and recommendations, and represent RA in governance forums, audits, and inspections as appropriate.
Portfolio Management
- Lead the regulatory execution for portfolio rationalization and planned phase outs of the ACM portfolio, establishing governance, milestones, resources, risks, and decision rights.
- Oversee market-by-market registration withdrawal, cancellation, transfer, or maintenance plans in alignment with commercial, quality, operations, supply chain, legal, and regional requirements.
- Ensure accurate transition and disposition of regulatory records and systems data, clear ownership of residual obligations, and completion of post-market and end-of-life commitments.
- Provide transparent progress reporting, risk escalation, and cross-functional coordination to enable an orderly exit while protecting patients, compliance, and business continuity.
People & Stakeholder Leadership
- Lead, coach, and develop a diverse team of professionals.
- Set a clear vision, roles, priorities, performance expectations, and development plans; build succession strength and an inclusive, accountable, high-performing culture.
- Determine resource allocation across competing priorities and build workforce and capability plans that support current execution and future needs.
- Communicate complex regulatory and operational topics with clarity across executive, cross-functional, and individual-contributor audiences; use strong written, presentation, and influencing skills to align stakeholders and accelerate decisions.
- Develop durable relationships with internal and external stakeholders and act as a trusted advisor to leadership on regulatory operating risk, execution readiness, and strategic business initiatives.
Must Have: Minimum Requirements
- Baccalaureate degree and a minimum of 10 years of relevant regulatory, quality, compliance, engineering, operations, or related experience, including 7+ years of managerial experience; or an advanced degree with a minimum of 8 years of relevant experience, including 7+ years of managerial experience.
- Demonstrated leadership of complex work in a highly regulated, global, and matrixed environment.
- Broad regulatory affairs foundation with the judgment to evaluate product, compliance, and business implications across the product lifecycle.
- Experience leading multiple disciplines or teams and delivering results through direct reports, cross-functional partners, and external service providers.
Nice to Have
- Advanced degree in science, engineering, regulatory affairs, business, law, or a related discipline.
- Medical device experience across premarket, sustaining, post-market, and product discontinuation activities.
- Experience with regulatory operations systems, data governance, metrics, digital transformation, automation, and process excellence.
- Experience with radiofrequency testing and registrations, wireless or connected devices, and third-party laboratory or registration partner oversight.
- Experience with business development, including distributed products, licensing, acquisitions, divestitures, strategic partnerships, or other BD&L transactions.
- Experience leading regulatory compliance programs, standards transitions, CAPAs, audits, inspections, field actions, or quality system governance.
- Proven success leading portfolio transitions, market exits, product discontinuations, or complex end-of-life programs.
- Executive presence and exceptional communication, presentation, negotiation, and influencing skills.
Differentiating Factors for Director Level Autonomy Leads a broad, multidisciplinary function with limited direction; establishes strategy, governance, and priorities and makes complex operational and selected strategic decisions. Organizational Impact Shapes the operating model and capabilities of ACM Regulatory Affairs. Decisions can materially affect compliance, market access, business continuity, resource deployment, and portfolio execution. Innovation & Complexity Solves ambiguous, cross-functional problems and significantly improves systems, processes, services, and organizational capabilities. Communication & Influence Builds long-term relationships and influences senior and executive leaders, enterprise functions, external partners, and technical teams with competing objectives. Leadership & Talent Leads multiple disciplines, establishes workforce and succession plans, develops leaders and specialists, and creates an inclusive, high-accountability culture.
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.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.
If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com . Benefits & Compensation
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):$194,400.00 - $291,600.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
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Posted 30 Oct 2026 · checked 31 Oct 2026 · Report this job