Sr Regulatory Affairs Manager
$154,400–$231,600 year
On-siteLafayette, Colorado, United States
Job Summary
Manage operational infrastructure, regulatory compliance programs, and product labeling capabilities for the Acute Care & Monitoring portfolio. Create and execute roadmaps for systems and process improvements, while leading continuous improvement efforts to automate repeatable work and eliminate manual tasks. Establish operational metrics and dashboards to monitor organizational effectiveness, and oversee global Unique Device Identifier (UDI) database implementation and administration. Stay abreast of worldwide regulations to communicate risks and mitigation strategies, and manage internal audit readiness, Notified Body surveillance, and inspection support activities. Provide operational direction for technical communications teams, overseeing the development, translation, and delivery of IFUs while driving the transition to eIFUs. Manage diverse teams of program managers and specialists, aligning resources to business priorities and defining clear performance goals and accountabilities.
Required Qualifications
- 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
- 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
- U.S. work authorization at the time of hire and for the duration of employment
Desired Qualifications
- 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
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