Chief Regulatory Officer – POC Device Compliance | Washington, DC

Are you a regulatory expert with a passion for advancing medical technology? We are seeking a seasoned Chief Regulatory Officer (CRO) to lead and oversee regulatory strategy and compliance for cutting-edge Point-of-Care (POC) medical devices. Based in Washington, DC, this is a mission-critical role that demands a deep understanding of FDA regulations, international standards, and diagnostic innovation. If you’re ready to drive regulatory excellence in a fast-evolving industry, this is your opportunity to lead.

Shape the Future of Medical Diagnostics from the Nation’s Capital

A pioneering healthcare technology company in Washington, DC is looking for a Chief Regulatory Officer to ensure strategic compliance across all facets of POC device development and commercialization. The ideal candidate will bring extensive experience with FDA submissions (510(k), PMA), CLIA waivers, and global regulatory frameworks. With the opportunity to influence product development and market access, this role is pivotal in accelerating patient access to life-saving diagnostic technologies.

Key Responsibilities of the Chief Regulatory Officer – POC Device Compliance

Regulatory Strategy & Leadership: Develop and lead a comprehensive global regulatory strategy for Point-of-Care (POC) devices, ensuring alignment with corporate objectives and evolving regulatory landscapes. Serve as the executive authority on all regulatory matters and guide product teams throughout the development lifecycle.

FDA & Global Compliance Oversight: Oversee all regulatory submissions including 510(k), PMA, CLIA waivers, and CE marking processes. Ensure full compliance with FDA, ISO, and other international regulatory bodies, while proactively monitoring changes in regulations and adapting internal policies accordingly.

Cross-Functional Collaboration: Partner with R&D, clinical, legal, and quality assurance teams to integrate regulatory considerations early in product development. Guide cross-functional efforts to ensure products meet both safety standards and commercialization timelines.

Regulatory Intelligence & Risk Mitigation: Maintain up-to-date knowledge of regulatory trends, policies, and guidance documents. Identify and mitigate potential regulatory risks by implementing proactive compliance systems and providing strategic input on product decisions.

Quality Systems & Audits: Collaborate with the Quality team to uphold a robust Quality Management System (QMS). Lead regulatory audits and inspections, ensuring readiness and successful outcomes from FDA and international authorities.

Product Lifecycle Management: Provide regulatory guidance from concept through post-market activities, including labeling, advertising, change control, and complaint handling. Ensure compliance throughout the product lifecycle to support sustained market presence.

Team Leadership & Development: Build and lead a high-performing regulatory affairs team. Mentor and develop staff, foster a culture of excellence, and promote continuous learning and professional development.

Regulatory Documentation & Submissions: Oversee the preparation, review, and submission of regulatory documents with a focus on accuracy, scientific integrity, and timely delivery. Ensure completeness and compliance across all submission types and formats.

Stakeholder Engagement & Communication: Act as the primary regulatory representative to executive leadership, the board, and external stakeholders. Communicate complex regulatory topics with clarity and confidence to drive informed decision-making.

Ethical Compliance & Corporate Integrity: Champion ethical business practices, transparency, and corporate governance in all regulatory activities. Ensure that products not only meet regulatory requirements but also align with patient safety and public health standards.

What the Client is Looking for in You

As the Chief Regulatory Officer (CRO) – POC Device Compliance, the client is seeking a visionary regulatory leader with deep expertise in navigating complex medical device regulations. You should be an experienced, detail-oriented executive who can balance innovation with rigorous compliance, ensure product readiness across multiple jurisdictions, and proactively shape regulatory strategy in a rapidly evolving healthcare technology environment.

Extensive Experience in Medical Device Regulation

The ideal candidate will have a strong background in regulatory affairs specific to medical devices, especially diagnostic or Point-of-Care (POC) technologies. Demonstrated success in securing FDA clearances (510(k), PMA), CLIA waivers, and EU CE marks is essential. The client values individuals who have effectively led regulatory submissions, audits, and compliance initiatives across global markets.

Strategic Regulatory Vision and Execution

You should be a strategic thinker capable of aligning regulatory pathways with business objectives. The client is looking for someone who can anticipate regulatory trends, assess risk, and develop scalable regulatory strategies that support product innovation, speed to market, and long-term compliance across all stages of the product lifecycle.

Expertise in Quality Systems and Risk Management

A solid understanding of ISO 13485, FDA QSR, and risk-based approaches to regulatory decision-making is critical. You should have hands-on experience guiding quality systems and ensuring audit readiness. Your ability to mitigate risk while maintaining a clear path to commercialization will be a key driver of success.

Proven Leadership and Cross-Functional Collaboration

As CRO, you will be expected to lead a high-performing regulatory affairs team and serve as a trusted advisor to executive leadership. The client values candidates who can inspire collaboration across R&D, Quality, Legal, and Commercial teams—ensuring that regulatory considerations are embedded throughout the organization.

Communication and Stakeholder Management

The client is looking for a confident communicator who can distill complex regulatory information for diverse audiences. Whether engaging with the FDA, internal teams, or the board of directors, your ability to present compliance strategies with clarity and authority will be paramount.

Commitment to Patient Safety and Ethical Compliance

Above all, the client seeks a regulatory leader who operates with integrity, prioritizes patient safety, and ensures the organization meets the highest ethical and legal standards. A strong commitment to continuous improvement and regulatory excellence is central to this role.

FAQs About the Role – Chief Regulatory Officer – POC Device Compliance

1. What are the key responsibilities of the Chief Regulatory Officer in this role?

As the Chief Regulatory Officer (CRO), you will be responsible for developing and executing regulatory strategies to ensure full compliance of Point-of-Care (POC) medical devices with FDA and international regulations. You will lead regulatory submissions, manage audit readiness, collaborate across teams to integrate regulatory requirements, and oversee quality systems to support product development and commercialization.

2. What qualifications and experience are required for this position?

The ideal candidate should have extensive experience in regulatory affairs for medical devices, particularly in POC diagnostics. Proven expertise with FDA submissions (510(k), PMA), CLIA waivers, and global regulatory frameworks is essential. A background in quality systems such as ISO 13485 and FDA QSR, coupled with strong leadership skills, is highly valued. An advanced degree in a relevant field or regulatory certification is preferred.

3. What leadership qualities are essential for this role?

The client seeks a strategic, detail-oriented leader with strong decision-making abilities and excellent communication skills. You should be able to inspire and guide cross-functional teams, manage complex regulatory challenges, and communicate regulatory concepts clearly to both technical and non-technical stakeholders. Integrity and a commitment to patient safety are paramount.

4. What challenges can I expect in this role?

Challenges include navigating evolving regulatory landscapes, balancing innovation with compliance, managing global regulatory submissions, and maintaining audit readiness. You will also need to coordinate among multiple departments to ensure seamless regulatory integration throughout the product lifecycle and mitigate potential compliance risks.

5. What impact is the Chief Regulatory Officer expected to have on the company?

The CRO is expected to enable faster market access for innovative POC devices by ensuring robust regulatory strategies and compliance. Your leadership will be critical in safeguarding product approvals, maintaining high-quality standards, and ultimately supporting the company’s mission to improve patient outcomes through accessible diagnostic technologies.

6. What is the company’s culture and work environment like?

The company fosters a collaborative, mission-driven environment focused on innovation and excellence in healthcare technology. They value transparency, continuous learning, and teamwork, providing employees with opportunities to grow professionally while contributing to meaningful advances in patient care.

What Remuneration Can You Expect from This Job?

As the Chief Regulatory Officer (CRO) – POC Device Compliance based in Washington, DC, you can expect a competitive and comprehensive compensation package designed to attract top-tier regulatory leadership in the healthcare and medical device sector. The remuneration for this role typically includes:

1. Base Salary

The base salary for a Chief Regulatory Officer in the medical device industry varies depending on company size, product portfolio, and market footprint. For a mid-to-large healthcare technology company, the annual base salary generally ranges from $200,000 to $400,000, with some leading organizations offering higher salaries based on experience and qualifications.

2. Performance-Based Bonuses

In addition to the base salary, CRO compensation often includes performance-based bonuses tied to regulatory milestones, successful product clearances, compliance achievements, and overall company growth. These bonuses typically range from 20% to 50% of the base salary, rewarding both individual and corporate success.

3. Equity & Stock Options

Many healthcare and medical device companies provide equity incentives such as stock options, restricted stock units (RSUs), or other long-term incentive plans. These equity components align executive rewards with company valuation and offer significant potential for wealth accumulation as the company grows and succeeds.

4. Long-Term Incentive Plans (LTIPs)

Some companies offer LTIPs or profit-sharing plans that incentivize sustained performance and compliance excellence over multiple years. These plans encourage strategic focus on long-term regulatory success and patient safety.

5. Executive Benefits & Perks

The compensation package typically includes a robust benefits suite such as:

Comprehensive health, dental, and vision insurance
401(k) plans with company matching contributions
Executive retirement plans
Professional development and certification reimbursement
Flexible work arrangements or remote work options
Travel allowances or company-sponsored conferences

6. Signing Bonuses & Relocation Assistance

To attract the right executive talent, companies may offer signing bonuses or relocation packages, especially for candidates relocating to the Washington, DC area. These one-time incentives can vary widely based on company policy and candidate experience.

Total Compensation Potential

Considering base salary, bonuses, equity incentives, and benefits, total annual compensation for a Chief Regulatory Officer in the POC device sector can range from approximately $300,000 to over $600,000. In high-growth or publicly traded companies, total remuneration can be significantly higher, reflecting the critical nature of the role in ensuring regulatory compliance and facilitating market access.

How to Apply

If you are a seasoned regulatory leader with deep expertise in Point-of-Care (POC) medical device compliance and a proven ability to navigate complex regulatory environments, we invite you to apply for the Chief Regulatory Officer (CRO) – POC Device Compliance position based in Washington, DC. This is a unique opportunity to lead regulatory strategy for innovative diagnostic technologies that impact patient care and market access.

To apply, please submit your resume along with a detailed cover letter highlighting your experience with FDA regulatory submissions (510(k), PMA), CLIA waivers, global compliance frameworks, quality systems management, and cross-functional leadership. Emphasize your ability to develop and execute regulatory strategies, lead audit readiness initiatives, and collaborate effectively with R&D, quality, and commercial teams.

This role offers a high-impact leadership opportunity where you will influence the future of medical diagnostics, drive regulatory excellence, and ensure compliance across product lifecycles. Apply today to take the next step in your regulatory career as Chief Regulatory Officer – POC Device Compliance in Washington, DC!

For more information or to explore similar regulatory leadership opportunities, please visit our Point-of-Care Device Executive Search Firm page.

Job Category: POC Device Compliance

Job Type: Full Time

Job Location: Washington

Chief Regulatory Officer – POC Device Compliance | Washington, DC