Sr Regulatory Affairs Manager

About the role

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.

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 reports timelines, milestones, and risks to product compliance programs that are actioned by a cross-functional team.
• Oversees the medical device data management for global Unique Device Identifier (UDI) database implementation programs (including EUDAMED).
• Oversees internal audit readiness, Notified Body surveillance activity, inspection support activities, compliance monitoring, and corrective action follow-up for RA-related work.
• Acts as a point of contact for Notified Body interaction including the submissions, deficiency responses, and certificate management.
• Provides operational direction for Technical Communications teams responsible for product labeling and documentation.
• Drives continuous improvement in documentation practices, tools, workflows, and content management processes, including hyperautomation initiatives.
• Drives the transition to eIFU across the ACM portfolio.
• Owes UDI administration, including GS1 GTIN issuance and hierarchy management.
• Manages and develops diverse teams of program managers, RA specialists, and technical communications leads.
• Absesses resource requirements based on business priorities and needs and allocates resources as required to meet those objectives.
• Clearly defines and articulates performance goals, with assigned accountabilities, clear decision authority, and an intense focus on alignment.
• Creates an environment that promotes clear communication (verbal and written), accountability, engagement, innovation, and continuous learning.

Requirements

• Minimum 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 bringing 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 Have

• 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.

Physical Job Requirements

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.

U.S. Work Authorization & Sponsorship

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.

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.