Sr Director, Quality & Regulatory Strategy and Operations (Hybrid - Acton, MA)

Senior Director, Quality & Regulatory Strategy & Operations

Reporting to: SVP, Chief Quality, Regulatory, and Compliance Officer
Location: Acton, MA

Role Overview

The Senior Director, Quality & Regulatory Strategy & Operations is a trusted strategic advisor and execution leader to the SVP - Chief Quality, Regulatory, and Compliance Officer (CQRCO). This role partners closely with the Quality, Regulatory, and Compliance Leadership Team, and cross‑functional leaders to define, operationalize, and deliver the enterprise Quality and Regulatory strategy.

Operating at the intersection of strategy, governance, and execution, this leader serves as the Chief of Staff to the CQRCO while also owning program and portfolio management for critical Quality, Regulatory, and Compliance initiatives. The role ensures strategic priorities are clearly defined, resourced, sequenced, and executed with rigor and transparency across the enterprise.

This is a highly visible, enterprise-facing role requiring strong strategic thinking, executive presence, systems leadership, and the ability to drive complex, multi-year transformation initiatives in a highly regulated medical device / healthcare environment.

Key Objectives

• 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

Key Responsibilities

Strategy & Enterprise Planning

• Partner with the CQRCO and senior leaders to define and articulate the long-term Quality, Regulatory, and Compliance strategy, aligned to corporate objectives and growth plans

• Lead development of the annual Quality & Regulatory strategic plan, including prioritization, sequencing, and resourcing of initiatives

• Conduct ongoing enterprise landscape assessments, including regulatory trends, enforcement themes, industry benchmarks, and emerging risks

• Lead scenario planning and strategic analyses to inform executive decisions related to compliance posture, risk mitigation, and growth-enabling strategies

Chief of Staff to the CQRCO

• Act as the CQRCO’s primary strategic and operational integrator, ensuring clarity, focus, and follow‑through across priorities

• Prepare executive briefings, strategic updates, and materials for ELT, Board, and external stakeholder engagements

• Drive leadership meeting agendas, decision forums, operating cadence, and follow-up actions to ensure accountability

• Facilitate communication and alignment across the Quality, Regulatory, and Compliance leadership team and the broader enterprise

Program & Portfolio Management

• Establish and oversee a portfolio management framework for Quality, Regulatory, and Compliance initiatives

• Lead execution of enterprise‑critical programs, including quality system transformations, regulatory readiness, remediation efforts, inspection preparedness, and capability buildouts

• Implement consistent program management standards, milestones, risk tracking, and dependency management

• Proactively identify delivery risks, constraints, and gaps; drive mitigation plans and escalation as needed

Cross-Functional Execution & Influence

• Serve as a connector across functions, aligning Quality & Regulatory priorities with R&D, Operations, Manufacturing, Supply Chain, IT, and Commercial partners

• Lead and influence without direct authority, mobilizing cross‑functional teams to drive outcomes

• Support change management and adoption of new processes, systems, and ways of working

• Ensure learnings from audits, inspections, and external feedback are translated into sustainable enterprise improvements

Governance, Metrics & Reporting

• Define and monitor enterprise-level KPIs related to Quality, Regulatory, and Compliance effectiveness

• Develop executive dashboards and performance reporting to support transparency and decision-making

• Support preparation for Board-level reviews, external audits, and regulatory engagements

Candidate Profile

The ideal candidate is a high‑caliber strategic leader with deep understanding of Quality, Regulatory, and Compliance within a regulated healthcare environment. They bring a calm, structured, and highly credible presence, thrive in ambiguity, and are energized by shaping strategy and ensuring flawless execution.

This leader is equally comfortable thinking strategically and operating tactically, serving as a trusted advisor to senior executives while driving disciplined execution across large, complex initiatives. They are collaborative, low‑ego, and naturally effective at influencing across boundaries.

Experience & Qualifications

• 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)

Core Leadership Competencies

Setting Strategy

• Articulates a clear, compelling vision that integrates Quality, Regulatory, and Compliance into enterprise value creation

• Applies data, insight, and judgment to shape priorities and inform decisions

• Balances ambition with practicality, ensuring strategies are executable and sustainable

Executing for Results

• Drives disciplined execution with clear accountability, milestones, and outcomes

• Navigates ambiguity with confidence and adaptability

• Anticipates risks and enables proactive mitigation

Leading Through Influence

• Builds trust rapidly across diverse stakeholders

• Leads complex initiatives without formal authority

• Fosters collaboration, alignment, and shared ownership

Integrity & Judgment

• Demonstrates sound judgment, transparency, and ethical leadership

• Operates with a strong enterprise mindset, balancing risk, compliance, and growth

NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office. #LI-Hybrid

Additional Information:

Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $198,200.00 - $297,350.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.