Director, Government Affairs

Posted 2 Days Ago
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Mahwah, NJ, USA
In-Office
160K-200K
Senior level
Hardware • Healthtech • Manufacturing
The Role
Lead federal and state government relations for a medical device company: develop and execute advocacy strategies, monitor regulatory and legislative developments (FDA, CMS, trade), advise executives, cultivate relationships with policymakers and agencies, represent the company externally, align cross-functional teams, manage risk and compliance (lobbying disclosures), and oversee external consultants.
Summary Generated by Built In

Description

**We are seeking a candidate local to the North American HQ office in Mahwah, NJ.**

A secondary location of Washington D.C. would be acceptable, with monthly visits to the NJ HQ office.

Join Mindray North America and help shape the future of patient care.

Mindray is a global leader in medical technology, delivering advanced patient monitoring systems, anesthesia machines, ventilators, and ultrasound solutions trusted in hospitals and critical care environments worldwide. Unlike many larger competitors, Mindray combines cutting-edge innovation with unmatched value, giving healthcare providers access to reliable, feature-rich technology without compromise. Our culture is built on collaboration, integrity, and a drive to equip caregivers with the tools they need to deliver exceptional care.

Fast facts about Mindray:

  • Founded in 1991, with 14,000 employees worldwide
  • 8 global R&D centers, investing ~10% of annual revenue into innovation
  • North American headquarters in Mahwah, NJ, with 40+ international subsidiaries

Position Overview

The Director of Government Affairs will develop and implement comprehensive government relations strategies aligned with corporate priorities. This leader will monitor healthcare policy developments, assess legislative and regulatory risks, and proactively shape policy outcomes that impact medical device approval, reimbursement, trade, and healthcare innovation.

This role requires deep knowledge of the healthcare and regulatory landscape, exceptional communication skills, and the ability to navigate complex policy environments with agility and influence.

Key Responsibilities

Government Relations Strategy

  • Develop and execute federal and state government affairs strategies aligned with corporate growth objectives.
  • Monitor, analyze, and interpret legislative and regulatory developments affecting medical device approval pathways, reimbursement structures, trade policy, and healthcare innovation.
  • Provide strategic counsel to the President and executive leadership regarding policy risks, emerging opportunities, and regulatory shifts.
  • Shape and advance advocacy priorities that support long-term business objectives.

External Engagement & Representation

  • Establish and maintain strong, productive relationships with key government agencies, healthcare regulatory bodies, centralized procurement entities, medical insurance organizations, and international institutions including Centers for Medicare & Medicaid Services (CMS), AdvaMed, WHO, UNDP, and UNICEF.
  • Cultivate and maintain relationships with Congressional offices, executive branch agencies, and key policymakers.
  • Actively participate in industry coalitions and contribute to the development of policy positions that advance the medical device sector.
  • Represent the organization at industry events, policy forums, conferences, and meetings with government officials and external stakeholders.

Internal Collaboration

  • Partner cross-functionally with sales, marketing, regulatory affairs, and legal teams to ensure advocacy efforts align with product strategy, commercialization goals, and regulatory positioning.
  • Translate complex policy developments into actionable insights for internal stakeholders.

Policy & Market Intelligence

  • Track and evaluate healthcare funding mechanisms, allocations, and reimbursement models within the designated market.
  • Provide regular, actionable reporting on policy changes, including regulatory updates, market access developments, and import/export controls.
  • Influence legislative and regulatory outcomes affecting medical device approval pathways and market access.

Compliance & Risk Oversight

  • Identify, assess, and mitigate risks arising from trade disputes, policy shifts, or regulatory changes that could impact operations.
  • Develop and implement proactive risk mitigation strategies.
  • Ensure full compliance with lobbying disclosure requirements and ethics regulations.
  • Oversee external lobbying firms and consultants where applicable

Qualifications

  • Bachelor’s degree or higher in a relevant field such as public health, pharmacy, medical science, public policy, economics, international relations, communications, or marketing.
  • Minimum of 8 years of experience in the public sector, healthcare industry (preferably medical devices), or related policy-focused roles.
  • Demonstrated experience influencing legislative or regulatory outcomes and advancing policy initiatives.
  • Established relationships with policymakers, regulatory officials, and industry  stakeholders; a strong network within government agencies and the medical device industry is highly valued.
  • Strong understanding of FDA regulatory frameworks and healthcare policy dynamics.
  • Exceptional written and verbal communication skills with the ability to engage effectively at executive and policymaker levels.
  • Strong analytical, strategic thinking, and problem-solving capabilities.
  • Proven ability to manage multiple initiatives simultaneously and operate effectively in cross-functional and cross-cultural environments.
  • Highly motivated, proactive, and results-driven.

Mindray North America offers a competitive compensation package and comprehensive benefits, including a 401(k) with company match, tuition reimbursement, paid time off, disability coverage, FSA/HSA options, and more—all within a dynamic, supportive, and collaborative work environment.

Mindray North America is an Equal Opportunity Employer M/F/D/V. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability, or any other legally protected status and will not be harassed or discriminated against. 

Skills Required

  • Local to Mahwah, NJ (Washington D.C. acceptable with monthly visits to NJ HQ)
  • Bachelor's degree or higher in public health, pharmacy, medical science, public policy, economics, international relations, communications, or marketing
  • Minimum of 8 years of experience in the public sector, healthcare industry (preferably medical devices), or related policy-focused roles
  • Demonstrated experience influencing legislative or regulatory outcomes and advancing policy initiatives
  • Established relationships with policymakers, regulatory officials, and industry stakeholders (strong network within government agencies and medical device industry)
  • Strong understanding of FDA regulatory frameworks and healthcare policy dynamics
  • Exceptional written and verbal communication skills with ability to engage at executive and policymaker levels
  • Strong analytical, strategic thinking, and problem-solving capabilities
  • Proven ability to manage multiple initiatives simultaneously and operate effectively in cross-functional and cross-cultural environments
  • Highly motivated, proactive, and results-driven
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The Company
0 Employees
Year Founded: 1991

What We Do

Mindray North America is a global leader in medical technology, specializing in the development and manufacture of medical devices. The company provides innovative solutions in three core areas: patient monitoring and life support, ultrasound, and in-vitro diagnostics. Its mission is to advance medical technologies to make healthcare more accessible, empowering healthcare professionals to deliver high-quality care through advanced medical imaging and critical care solutions.

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