VP of Global Regulatory Affairs – Medical Device Firm – Irvine, CA

Are you an accomplished regulatory leader with deep expertise in navigating global medical device regulations? We are seeking a Vice President of Global Regulatory Affairs to guide a rapidly growing medical device company headquartered in Irvine, CA. This is a unique opportunity to shape regulatory strategy, ensure global compliance, and drive market access for innovative, life-changing medical technologies. If you excel in complex regulatory environments and have a passion for advancing healthcare solutions, this role is designed for you.

Lead Global Regulatory Strategy for a High-Growth Medical Device Innovator

A leading medical device firm based in Irvine, CA is seeking a VP of Global Regulatory Affairs to oversee worldwide regulatory operations and product approvals. The ideal candidate will bring extensive experience in FDA, EU MDR, and global regulatory frameworks, along with a strong track record of successful submissions for Class II and Class III devices. If you are driven by the challenge of accelerating product launches, leading high-performing regulatory teams, and ensuring compliance across international markets, this is your opportunity to make a significant impact in a mission-driven organization.

Key Responsibilities of the VP of Global Regulatory Affairs – Medical Device Industry

Global Regulatory Strategy & Leadership

Develop and execute a comprehensive global regulatory strategy that supports timely product approvals and successful market expansion. Ensure alignment between regulatory initiatives, business objectives, and evolving international medical device regulations across the U.S., EU, APAC, LATAM, and emerging markets.

Regulatory Compliance & Quality Oversight

Ensure all products comply with FDA regulations (including 510(k), PMA, and De Novo pathways), EU MDR/IVDR requirements, and global standards. Oversee regulatory audits, risk assessments, and quality system compliance to maintain exceptional standards of safety, performance, and documentation.

Product Submission & Approval Management

Lead preparation, review, and submission of regulatory filings for Class II and Class III devices. Manage global product registrations, labeling reviews, design dossiers, and technical files to ensure efficient approvals and regulatory clearance for new and existing products.

Cross-Functional Collaboration

Partner closely with R&D, Quality, Clinical, Manufacturing, and Marketing teams to support product development, clinical trial planning, and design controls. Provide regulatory guidance throughout the product lifecycle to minimize delays, ensure alignment, and accelerate launches.

Regulatory Intelligence & Risk Mitigation

Monitor global regulatory changes, competitive product approvals, and evolving industry standards. Proactively assess regulatory risks, develop mitigation strategies, and advise executive leadership on regulatory impacts to the business and product pipeline.

Team Leadership & Development

Lead, mentor, and grow a high-performing global regulatory affairs team. Establish clear goals, oversee resource planning, and foster a culture of continuous learning, accountability, and operational excellence.

External Relations & Stakeholder Engagement

Build strong relationships with regulatory agencies, notified bodies, industry associations, and external partners. Represent the company in regulatory discussions, agency meetings, and advisory boards to advocate for product approvals and maintain regulatory trust.

What the Client is Looking for in You

Proven Expertise in Global Medical Device Regulations

The client is seeking a seasoned regulatory affairs executive with extensive experience navigating FDA, EU MDR, and international medical device standards. You should have a strong record of leading regulatory submissions, achieving successful approvals, and guiding companies through complex compliance landscapes.

Strategic, Forward-Thinking Regulatory Leadership

As VP of Global Regulatory Affairs, you must bring a strategic mindset capable of developing long-term regulatory plans that support innovation and global expansion. The ideal candidate excels at anticipating regulatory shifts, aligning regulatory strategy with business goals, and influencing key decisions across the organization.

Deep Understanding of Product Development & Clinical Pathways

The client values leaders who understand design controls, risk management, clinical evaluation, and post-market surveillance. You should be able to guide cross-functional teams with clear regulatory insights that accelerate development while ensuring compliance.

Strong Communication & Agency Engagement Skills

This role requires exceptional communication abilities to interface effectively with FDA officials, notified bodies, and global regulators. The ideal candidate can clearly present regulatory strategies, negotiate approvals, and maintain productive, transparent agency relationships.

Leadership Ability to Build & Develop High-Performing Teams

The client seeks a leader who can inspire, mentor, and empower regulatory professionals across multiple regions. A collaborative leadership style, strong people-development skills, and the ability to manage a global team are essential.

Data-Driven Decision-Making & Risk Management

You should demonstrate strong analytical skills, the ability to interpret regulatory guidance, and the judgment to make data-backed decisions. Experience in identifying regulatory risks and developing proactive mitigation plans is highly valued.

Commitment to Compliance, Ethics & Operational Excellence

The client wants a leader who prioritizes regulatory integrity, quality, and ethical practices. A commitment to maintaining compliant operations and upholding global industry standards is a must.

FAQs About the Role – VP of Global Regulatory Affairs – Medical Device Industry

1. What are the key responsibilities of the VP of Global Regulatory Affairs?

You will lead global regulatory strategy, ensure compliance with FDA and international regulations, oversee regulatory submissions, manage global product approvals, and guide cross-functional teams through product development and commercialization. You will also engage with regulatory agencies and lead a global regulatory team.

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

The ideal candidate has 10+ years of regulatory affairs experience within the medical device industry, with strong expertise in FDA pathways (510(k), PMA, De Novo), EU MDR/IVDR, and international regulatory frameworks. Experience with Class II/III devices, global product registrations, and leading regulatory teams is essential. Advanced degrees in science, engineering, or regulatory affairs are preferred.

3. What leadership qualities are essential for this role?

This role requires a strategic thinker with excellent communication, decision-making, and team leadership skills. The client seeks someone who can inspire teams, manage complex regulatory challenges, collaborate across departments, and effectively represent the company in front of regulatory bodies.

4. What challenges can I expect in this role?

You may face challenges such as evolving global regulations (e.g., EU MDR), tight submission timelines, managing diverse regional requirements, and balancing regulatory compliance with innovation speed. Navigating agency expectations and aligning global teams will also be key aspects of the role.

5. What impact is the VP of Global Regulatory Affairs expected to make?

You will play a critical role in driving global market access, accelerating product launches, ensuring compliance, and supporting the company’s growth strategy. Your leadership will influence regulatory readiness, product quality, risk mitigation, and overall business success.

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

The company promotes a collaborative, science-driven, and innovation-focused environment. They value leaders who emphasize integrity, teamwork, accountability, and continuous improvement. The VP will have the opportunity to shape regulatory culture and elevate cross-functional excellence.

What Remuneration Can You Expect from This Job?

As the VP of Global Regulatory Affairs – Medical Device Industry in Irvine, CA, you can expect a highly competitive and comprehensive executive compensation package designed to attract top regulatory leaders. The remuneration typically includes:

1. Base Salary

Compensation for a VP of Global Regulatory Affairs in the medical device sector varies based on company size, product portfolio, and global reach. In a mid-to-large medical device organization, the base salary generally ranges from $220,000 to $350,000 annually, with larger or publicly traded firms offering higher salary bands.

2. Performance-Based Bonuses

Most compensation packages include annual bonuses tied to key regulatory and business outcomes, such as timely product approvals, successful global submissions, regulatory compliance performance, and team leadership excellence. Bonuses typically range from 20% to 50% of the base salary, depending on individual and organizational results.

3. Equity & Stock Options

Equity compensation is a common component of senior regulatory roles in medical device companies. This may include stock options, RSUs (Restricted Stock Units), or performance-based equity awards. These incentives align leadership performance with company growth and provide significant long-term financial rewards.

4. Long-Term Incentive Plans (LTIPs)

Some organizations offer multi-year incentive plans that reward sustained regulatory success, global expansion, and long-term strategic contributions. LTIPs often include additional cash incentives or equity grants tied to multi-year milestones and overall company performance.

5. Executive Benefits & Perks

As a senior executive, you can expect a robust suite of benefits, including:

Comprehensive health, dental, and vision insurance
401(k) plan with company contributions
Executive-level retirement or deferred compensation plans
Paid time off and flexible work options
Professional development & global conference participation
Executive wellness programs
Travel benefits for international regulatory engagement

6. Signing Bonuses & Relocation Assistance

For top-tier candidates, companies may offer signing bonuses or relocation packages, especially for those moving to Irvine, CA. These incentives may range from $20,000 to over $100,000, depending on experience and organizational urgency.

Total Compensation Potential

When combining base salary, bonuses, long-term incentives, and equity, total compensation for a VP of Global Regulatory Affairs can range from $300,000 to over $600,000 annually, with higher packages at fast-growing, global, or publicly traded medical device companies.

How to Apply

If you are a strategic, forward-thinking regulatory leader with a proven track record in the medical device industry, we invite you to apply for the VP of Global Regulatory Affairs – Medical Device Firm – Irvine, CA. This is an exceptional opportunity to lead global regulatory strategy, shape compliance excellence, and accelerate access to life-changing medical innovations across worldwide markets.

To apply, please submit your resume and a cover letter detailing:

Your experience in global regulatory strategy and leadership
FDA, EU MDR/IVDR, and international regulatory expertise
Success leading Class II and Class III regulatory submissions
Your track record in cross-functional collaboration and product development
Experience building and managing high-performing global teams
Examples of regulatory approvals, risk mitigation, and compliance excellence

Highlight your ability to navigate complex global regulations, influence executive decisions, and drive regulatory readiness across diverse regions.

This role offers a high-impact leadership opportunity where you will shape regulatory strategy, accelerate product innovation, and contribute directly to global patient safety and access. Apply today to take the next step in your executive career as VP of Global Regulatory Affairs.

For more information or to explore similar leadership roles, visit our Regulatory Affairs Executive Search Firm Page.

Job Category: Regulatory Affairs

Job Type: Full Time

Job Location: Irvine

VP of Global Regulatory Affairs – Medical Device Firm – Irvine, CA