Sr Regulatory Affairs Manager

## Responsable sr des Affaires réglementaires

Postulerremote type:
Sur site locations:
Lafayette, Colorado, United States of America time type:
Temps pleinposted on:
Offre publiée aujourd'huitime left to apply:
Date de fin : 31 juillet 2026 (Il reste 23 jour(s) pour postuler) job requisition :
R70947

We anticipate the application window for this opening will close on - 31 Jul 2026

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** Journée type*
* ** Senior Manager, Regulatory Affairs Operations & Technical Communications
**** Careers That Change Lives
** 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.
** A Day in the Life
**** RA Operations
*** 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.
** Regulatory Compliance
*** 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.
** Technical Communications
*** 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.
** Team & Resource 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.
*…