Senior Regulatory Affairs Manager
Job in
Arvada, Jefferson County, Colorado, 80004, USA
Listed on 2026-07-20
Listing for:
Jobtailor
Full Time
position Listed on 2026-07-20
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist -
Management
Regulatory Compliance Specialist, Change Management
Job Description & How to Apply Below
Responsibilities
- Lead and develop a high‑performing team focused on product release and regulatory execution
- Lead end‑to‑end regulatory product release strategy and execution, ensuring compliance with global regulatory requirements
- Drive process standardization, simplification, and automation across product release workflows
- Lead data quality initiatives to support compliant global submissions and product distribution
- Oversee regulatory distribution control processes (e.g., GTS/SAP) to enable timely and accurate product release
- Lead continuous improvement initiatives focused on cycle time, quality, and scalability of release processes
- Establish and monitor KPIs, dashboards, and reporting to track performance and compliance
- Build organizational capability in regulatory systems, data, and operational execution
- Bachelor’s degree
- 7+ years of experience supporting or leading product release, distribution control, or regulatory operations processes (or 5+ years with advanced degree)
- 5+ years of managerial experience
- Strong knowledge of global regulatory requirements impacting product distribution (FDA, EU MDR, international markets)
- Organizational skills and highly detail oriented
- Intermediate knowledge of spreadsheet and database applications (Microsoft Office, and SharePoint)
- Analytical and problem‑solving skills
- Effective project management skills
- Experience with GTS/SAP, UDI (GUDID/EUDAMED), and/or RIM systems
- Experience in regulatory data management, governance, or digital transformation
- Experience driving process harmonization across global organizations
- Proven ability to work in complex, matrixed organizations and influence stakeholders
- 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.
Position Requirements
10+ Years
work experience
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