Senior Manager, Regulatory Operations and Transformation
$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 a roadmap for RA initiatives, utilizing validated data to automate repeatable processes and eliminate redundant manual work. Establish operational metrics and dashboards to drive visibility into organizational effectiveness while overseeing global Unique Device Identifier (UDI) database implementation and internal audit readiness. Stay abreast of worldwide regulations to communicate risks, manage Notified Body interactions, and oversee corrective actions. Provide operational direction for technical communications, overseeing the development and transition to electronic IFUs across the ACM product line. Lead a multidisciplinary team of program managers and specialists, defining performance goals and aligning resources to meet business priorities.
Required Qualifications
- Bachelor's degree in Science, Engineering, Business Administration, or related discipline
- Minimum of 7 years of experience combined in regulatory operations
- 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
- Experience with automation initiatives
- Experience with workflow optimization efforts
- 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
- 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
- Demonstrate leadership courage through bold thinking and change management
- Ability to attract, recruit, mentor, and retain high-caliber professionals
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.