VP of Global Compliance – Drug-Device Regulations | Silver Spring, MD

Are you an accomplished regulatory expert with a proven track record in navigating complex global drug and device regulations? We are seeking a Vice President of Global Compliance to lead and elevate the regulatory compliance strategy for a cutting-edge healthcare company based in Silver Spring, MD. This leadership role offers the unique opportunity to shape global compliance frameworks, ensure regulatory excellence, and support the delivery of innovative drug-device combination products worldwide.

Drive Regulatory Excellence on a Global Scale

A leading healthcare organization in Silver Spring, MD is looking for a strategic and experienced Vice President of Global Compliance to oversee all regulatory compliance aspects related to drug-device products. The ideal candidate will possess deep expertise in FDA, EMA, and international regulatory landscapes, combined with strong leadership capabilities to manage global compliance teams. If you excel in interpreting evolving regulations, mitigating risk, and fostering cross-functional collaboration, this role empowers you to make a significant impact on product integrity and patient safety worldwide.

Key Responsibilities of the Vice President of Global Compliance – Drug-Device Regulations

Regulatory Strategy & Leadership: Develop and execute a comprehensive global compliance strategy for drug-device combination products that aligns with evolving regulatory landscapes. Lead the design and implementation of robust compliance frameworks to ensure seamless product approvals and market access worldwide.

Global Regulatory Oversight: Oversee compliance with FDA, EMA, PMDA, and other key regulatory bodies. Ensure all drug-device products meet applicable regulatory requirements across diverse international markets, maintaining adherence to quality and safety standards.

Cross-Functional Collaboration: Partner closely with R&D, Quality Assurance, Clinical, Manufacturing, and Legal teams to embed regulatory compliance into all stages of product development and lifecycle management. Facilitate smooth regulatory submissions and audits.

Risk Management & Mitigation: Identify, assess, and mitigate regulatory risks related to drug-device product development and commercialization. Establish proactive policies and procedures to reduce compliance gaps and protect the organization from regulatory actions.

Team Leadership & Development: Build, mentor, and lead a high-performing global compliance team. Foster a culture of continuous learning, accountability, and regulatory excellence to support business objectives.

Regulatory Intelligence & Advocacy: Monitor and interpret changes in global drug-device regulations and guidance. Represent the company in regulatory forums, industry associations, and with health authorities to influence policies and ensure preparedness.

Compliance Training & Communication: Design and implement training programs to promote regulatory awareness and adherence across the organization. Ensure clear communication of compliance requirements to all relevant stakeholders.

Audit & Inspection Readiness: Prepare and support internal and external regulatory inspections, audits, and reviews. Lead corrective and preventive actions (CAPA) to address compliance findings and enhance regulatory standing.

What the Client is Looking for in You

As the Vice President of Global Compliance – Drug-Device Regulations, the client seeks a seasoned regulatory leader with deep expertise in drug-device combination products and a proven ability to lead global compliance efforts. You should be a strategic, detail-oriented professional who thrives in a complex, highly regulated healthcare environment and can drive regulatory excellence across multiple international markets.

Proven Expertise in Drug-Device Regulatory Compliance

The client is looking for an individual with extensive experience navigating FDA, EMA, and other major regulatory agencies’ requirements for drug-device products. You should have a strong track record of successfully leading regulatory submissions, audits, and inspections, and ensuring ongoing compliance throughout the product lifecycle.

Strategic Regulatory Leadership

You must demonstrate the ability to develop and execute forward-looking compliance strategies that align with business goals and global regulatory changes. The ideal candidate anticipates regulatory trends, adapts quickly, and ensures that the organization maintains a competitive advantage while managing risk effectively.

Strong Risk Management and Problem-Solving Skills

The role requires a proactive mindset in identifying and mitigating regulatory risks related to product development and commercialization. The client values leaders who can develop robust compliance frameworks and implement corrective actions swiftly and efficiently.

Ability to Build and Lead High-Performing Global Teams

Leadership is essential for this role. The client seeks someone who can inspire, develop, and retain top compliance talent across geographies. You should foster a collaborative culture centered on continuous improvement, regulatory excellence, and accountability.

Excellent Communication and Stakeholder Management

The ideal candidate communicates complex regulatory requirements clearly to cross-functional teams and senior executives. You should excel at building trusted relationships with regulatory authorities, internal stakeholders, and external partners, advocating for the company’s interests while ensuring transparency.

Commitment to Quality and Ethical Compliance

The client values a leader who prioritizes quality, patient safety, and ethical business practices. You should have a strong commitment to maintaining the highest standards of regulatory compliance and corporate governance in a fast-evolving industry landscape.

FAQs About the Role – Vice President of Global Compliance – Drug-Device Regulations

1. What are the key responsibilities of the VP of Global Compliance in this role?
As the Vice President of Global Compliance, you will lead the development and implementation of regulatory compliance strategies for drug-device combination products. Your responsibilities include ensuring global regulatory adherence, managing compliance risks, overseeing cross-functional collaboration, and leading a high-performing compliance team. You will also serve as the primary liaison with regulatory authorities and ensure audit and inspection readiness.

2. What qualifications and experience are required for this position?
The ideal candidate should have extensive experience in regulatory affairs, specifically with drug-device combination products, and a strong understanding of global regulatory frameworks including FDA, EMA, and other international agencies. Proven leadership in managing global compliance teams and driving regulatory strategy is essential. Advanced degrees in life sciences, pharmacy, or related fields are preferred, alongside relevant certifications.

3. What leadership qualities are essential for this role?
The client seeks a strategic and collaborative leader with strong problem-solving skills and the ability to navigate complex regulatory environments. Excellent communication, team-building capabilities, and the ability to influence stakeholders across multiple regions are critical. You should be proactive, adaptable, and committed to maintaining the highest standards of compliance and ethics.

4. What challenges can I expect in this role?
You will face challenges such as managing regulatory changes across diverse markets, coordinating compliance across multiple product lines, and balancing innovation with stringent regulatory requirements. Leading a global team through evolving regulations and preparing for regulatory inspections will also be key challenges in this dynamic environment.

5. What is the expected impact of the VP of Global Compliance on the company’s success?
Your leadership will be instrumental in ensuring the company’s products meet global regulatory standards, facilitating timely product launches, and minimizing compliance risks. By maintaining regulatory excellence, you will help safeguard the company’s reputation, support business growth, and ultimately improve patient safety worldwide.

6. What is the company’s culture and work environment like?
The company values innovation, integrity, and collaboration within a fast-paced and highly regulated industry. They foster a culture of continuous learning and accountability, encouraging employees to take initiative while working as a cohesive team. You will have the opportunity to shape the compliance function while partnering closely with cross-functional leaders.

What Remuneration Can You Expect from This Job?

As the Vice President of Global Compliance – Drug-Device Regulations based in Silver Spring, MD, you can expect a competitive and comprehensive compensation package designed to attract and retain top regulatory leadership talent. The remuneration typically includes:

1. Base Salary
The base salary for a VP-level compliance role in the pharmaceutical and medical device industry generally ranges from $180,000 to $300,000 annually, depending on company size, product portfolio complexity, and candidate experience.

2. Performance-Based Bonuses
In addition to the base salary, most compensation packages include annual performance bonuses tied to regulatory milestones, compliance achievements, risk mitigation, and overall business impact. These bonuses can range from 20% to 50% of the base salary.

3. Equity & Stock Options
Many organizations offer equity incentives such as stock options or restricted stock units (RSUs) to align your interests with long-term company growth and shareholder value. These can form a significant part of your total compensation, especially in publicly traded or high-growth companies.

4. Long-Term Incentive Plans (LTIPs)
Some companies provide LTIPs or profit-sharing arrangements to reward sustained performance over multiple years, encouraging a focus on continuous compliance excellence and business stability.

5. Executive Benefits & Perks
Typical benefits include:

Comprehensive health, dental, and vision insurance
Retirement plans such as 401(k) with company matching
Paid time off and wellness programs
Professional development and certification support
Travel allowances for global regulatory meetings and inspections

6. Signing Bonuses & Relocation Assistance
For highly qualified candidates, signing bonuses or relocation packages may be offered to facilitate a smooth transition to the role. These incentives vary based on company policy and candidate circumstances.

Total Compensation Potential

Considering base salary, bonuses, equity, and benefits, the total annual compensation for a VP of Global Compliance can range from approximately $250,000 to $450,000 or more. In leading pharmaceutical or medical device companies, the package may be even more competitive to secure top executive talent.

How to Apply

If you are an experienced and visionary leader with a proven track record in global regulatory compliance for drug-device combination products, we invite you to apply for the Vice President of Global Compliance – Drug-Device Regulations role based in Silver Spring, MD. This is an exceptional opportunity to lead compliance strategy, drive regulatory excellence, and influence the global lifecycle of innovative combination products.

To apply, please submit your resume along with a cover letter highlighting your experience in drug-device regulatory affairs, global compliance management, risk mitigation strategies, and leadership of high-performing regulatory teams. Emphasize your ability to navigate complex regulatory landscapes, ensure inspection readiness, and collaborate across functions to support product innovation and market access.

This role offers a significant leadership opportunity to shape compliance frameworks and safeguard the company’s reputation while enabling sustainable growth. Apply today to advance your career as a strategic compliance leader in the pharmaceutical and medical device industry.

For more information or to explore similar leadership opportunities, please visit our Executive Search for Regulatory Affairs in Combination Products Page.

Job Category: Drug-Device Regulations

Job Type: Full Time

Job Location: Silver Spring

VP of Global Compliance – Drug-Device Regulations | Silver Spring, MD