GRC Analyst supporting ISO27001 certification preparation at Asiera. Collaborating with technical teams for documentation and compliance.
DF
Hybrid Senior Director, Quality and Regulatory Strategy and Operations
Posted 6 days ago
About the role
- Senior Director overseeing Quality & Regulatory Strategy for innovative medical device company. Partnering with executives to drive compliance and operational excellence in a regulated environment.
Responsibilities
- Serve as a strategic thought partner and Chief of Staff to the SVP, CQRCO
- Translate Quality, Regulatory, and Compliance vision into clear enterprise strategy and execution roadmaps
- Establish governance, operating cadence, and program management discipline across Quality & Regulatory initiatives
- Drive cross-functional alignment and execution of high‑priority, enterprise‑critical programs
- Enable executive decision-making through insightful analysis, scenario planning, and performance tracking
- Support organizational readiness for regulatory inspections, audits, and major external milestones
- Strengthen integration and coordination across Quality, Regulatory, Compliance, R&D, Manufacturing, Supply Chain, and Commercial teams
Requirements
- Bachelor’s degree required; advanced degree (MBA, MS, PhD, JD) strongly preferred
- 12+ years of progressive experience in Quality, Regulatory Affairs, Compliance, Strategy, PMO, or Management Consulting
- Demonstrated experience supporting or partnering with C‑suite or senior executive leaders in a Chief of Staff, strategy, or enterprise PMO capacity
- Deep understanding of FDA regulations, global regulatory frameworks, quality systems, and inspection readiness
- Proven track record leading complex, cross‑functional enterprise programs with material business impact
- Strong analytical capabilities, with the ability to synthesize complex data into clear executive insights
- Exceptional communication skills (written, verbal, executive presence).
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
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