Sr Regulatory Affairs Manager

Medtronic • Lafayette, CO

3d • $154,400 - $231,600 • Remote

About The Position

The Senior Manager, Regulatory Affairs (RA) Operations & Technical Communications is responsible for managing the operational infrastructure, regulatory compliance programs, and product labeling capabilities that enable a high-performing RA organization. This leader supports continuous improvement and operational advancement across the RA function, and the sustained compliance to global regulatory requirements and management of IFUs within the Acute Care & Monitoring (ACM) product portfolio. As a member of the RA leadership team, this role collaborates closely with the network of RA leaders along with cross-functional team members across the operating unit to ensure RA is equipped with the tools, processes, and systems needed to execute effectively throughout the full product lifecycle. The Senior Manager leads a multidisciplinary team grounded in accountability, collaboration, operational excellence, and continuous improvement.

Requirements

• Bachelor's degree in Science, Engineering, Business Administration, or related discipline.
• Minimum of 7 years of experience combined in regulatory operations with 5+ years of managerial experience.
• Demonstrated experience leading operational improvement initiatives within a complex, matrixed, and highly regulated environment.
• Experience implementing digital solutions and software, automation initiatives, and workflow optimization efforts.
• Experience prioritizing work, leading and empowering team members, and driving tasks to completion.
• Demonstrated success building and leading high-performing teams.
• Ability to think strategically, to detect the essence of complex or ambiguous issues, and to put these in the context of larger, systemic issues.
• Strong business orientation - ability to communicate and interact effectively with senior business leaders.
• Strong background in project management with demonstrated success at bring projects to completion on time.
• Ability to inspire, motivate, and build the confidence of teams to reach goals, steadfastly pushing self and others to achieve results.
• Demonstrate leadership courage through bold thinking and change management.
• Ability to attract, recruit, mentor, and retain high-caliber professionals.

Nice To Haves

• Strong knowledge of global regulatory requirements and quality systems.
• Experience leading product labeling, publishing, content development, and/or documentation teams.
• Knowledge of monitoring and/or diagnostic medical devices preferred.
• 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

• Represents the ACM RA Function for RA Initiatives across the Enterprise.
• Create and execute against a roadmap for RA that shows the systems, process, and operational improvements for the function.
• Lead continuous improvement efforts to reduce redundant manual work across RA by using validated data, building tools that automate repeatable processes, and eliminating unnecessary work.
• Establish and maintain operational metrics, dashboards, and performance measures that provide visibility into organizational effectiveness for RA operations and technical communications.
• Drive adoption of best practices and operational standards across the organization for processes and tools that support regulatory work across the product lifecycle.
• Stays abreast of worldwide regulations and standards and communicates potential risks and mitigation strategies to stakeholders.
• Clearly report timelines, milestones, and risks to product compliance programs that are actioned by a cross functional team.
• Oversee the medical device data management for global Unique Device Identifier (UDI) database implementation programs (including EUDAMED).
• Oversee internal audit readiness, Notified Body surveillance activity, inspection support activities, compliance monitoring, and corrective action follow-up for RA-related work.
• Act as a point of contact for Notified Body interaction including the submissions, deficiency responses, and certificate management.
• Provide operational direction for Technical Communications teams responsible for product labeling and documentation.
• Act as a steward of technical communications and oversee development, translation, and delivery of IFUs for all products within the ACM portfolio.
• Drive continuous improvement in documentation practices, tools, workflows, and content management processes, including hyperautomation initiatives.
• Drive the transition to eIFU across the ACM portfolio.
• Own UDI administration, including GS1 GTIN issuance and hierarchy management.
• Manages and develops diverse teams of program managers, RA specialists, and technical communications leads.
• Assess resource requirements based on business priorities and needs and allocates resources as required to meet those objectives.
• Able to align capabilities to project work as it evolves over time.
• Clearly defines and articulates performance goals, with assigned accountabilities, clear decision authority, and an intense focus on alignment.
• Create an environment that promotes clear communication (verbal and written), accountability, engagement, innovation, and continuous learning.

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: Manager