Chief Regulatory Officer (Med Device) in Irvine, CA

Chief Regulatory Officer (Med Device) in Irvine, CA

Are you a seasoned regulatory affairs expert with a deep understanding of medical device compliance and global regulatory frameworks? We are seeking a Chief Regulatory Officer (Med Device) in Irvine, CA, to lead regulatory strategy, ensure compliance with FDA and international regulations, and drive successful product approvals. This executive role demands a highly experienced professional who can navigate complex regulatory environments while aligning compliance efforts with business growth objectives.

As the Chief Regulatory Officer (Med Device) in Irvine, CA, you will be responsible for overseeing regulatory submissions, developing policies that meet global standards, and collaborating with internal teams to streamline compliance. If you have a strong background in regulatory leadership within the medical device sector and excel at balancing innovation with regulatory requirements, we encourage you to apply for this pivotal role.

About This Role

The Chief Regulatory Officer (Med Device) in Irvine, CA, plays a crucial role in shaping the regulatory landscape for the company, ensuring that all products comply with FDA, EU MDR, ISO, and other global regulations. This position requires a visionary leader who can craft and execute regulatory strategies, oversee clinical trial approvals, and mitigate compliance risks while accelerating product launch timelines.

In this role, you will drive regulatory excellence, manage interactions with regulatory agencies, and lead a team of compliance professionals to ensure seamless product approvals. The Chief Regulatory Officer (Med Device) in Irvine, CA, will serve as a key advisor to the executive leadership team, ensuring that all regulatory initiatives align with business goals while maintaining the highest standards of safety and efficacy. This is an exceptional opportunity to shape regulatory strategy at a fast-growing medical device company while making a significant impact on patient care and global healthcare innovation.

Key Responsibilities – Chief Regulatory Officer (Med Device) in Irvine, CA

Develop and Implement Global Regulatory Strategies

  • Design and execute regulatory roadmaps that align with business objectives and product development timelines.
  • Ensure compliance with FDA, EU MDR, ISO 13485, and other international medical device regulations.
  • Develop regulatory pathways for product approvals in existing and emerging global markets.

Lead Regulatory Submissions and Product Approvals

  • Oversee the preparation and submission of 510(k)s, PMAs, IDEs, and CE Mark applications.
  • Manage responses to regulatory inquiries and lead negotiations with regulatory authorities.
  • Develop and implement strategies to expedite product approvals and market entry.

Ensure Compliance with Evolving Regulatory Standards

  • Monitor changes in global regulatory requirements and update company policies accordingly.
  • Establish internal compliance programs to ensure adherence to new regulations and industry best practices.
  • Work cross-functionally with R&D, clinical, and quality teams to maintain compliance throughout product lifecycles.

Oversee Clinical Trial Approvals and Compliance

  • Collaborate with clinical teams to ensure regulatory approval for clinical trials.
  • Provide regulatory guidance on study design, data collection, and ethical considerations.
  • Ensure adherence to Good Clinical Practice (GCP) and clinical trial regulations.

Manage Regulatory Risk and Crisis Resolution

  • Identify potential regulatory risks and develop strategies for mitigation.
  • Lead resolution efforts for regulatory challenges, audits, and compliance investigations.
  • Act as the primary liaison with regulatory bodies during inspections and audits.

Lead a High-Performing Regulatory Affairs Team

  • Build and mentor a team of regulatory affairs professionals.
  • Foster a culture of compliance, continuous learning, and regulatory excellence.
  • Implement training programs to keep teams informed of regulatory updates and best practices.

Drive Regulatory Innovation and Business Growth

  • Align regulatory strategies with business objectives to support market expansion.
  • Influence corporate decision-making with data-driven regulatory insights.
  • Ensure regulatory considerations are integrated into product development from inception.

Represent the Company in Regulatory Affairs Matters

  • Engage with industry associations, regulatory agencies, and key stakeholders to influence policy discussions.
  • Serve as the company’s spokesperson for regulatory affairs at conferences, panels, and industry events.
  • Establish credibility and thought leadership in the regulatory landscape for medical devices.

What The Client is Looking For in You

To excel as the Chief Regulatory Officer (Med Device) in Irvine, CA, you should bring a combination of strategic regulatory leadership, deep industry expertise, and a results-oriented mindset. The ideal candidate will possess:

  • Extensive Regulatory Experience in the Medical Device Industry – A strong background in regulatory affairs, with proven expertise in FDA submissions (510(k), PMA, IDE), EU MDR compliance, ISO 13485, and other global regulatory frameworks.
  • Proven Leadership in Regulatory Strategy – Demonstrated ability to develop and execute regulatory roadmaps that align with business goals while ensuring compliance across multiple markets.
  • Strong Knowledge of Clinical and Quality Standards – Familiarity with clinical trial regulations, Good Clinical Practice (GCP), risk management, and quality management systems (QMS).
  • Excellent Communication and Negotiation Skills – Experience liaising with regulatory agencies, responding to inquiries, and leading negotiations for product approvals.
  • Risk Management and Compliance Expertise – Ability to anticipate regulatory challenges, mitigate compliance risks, and implement proactive solutions.
  • Leadership and Team Development – A track record of mentoring high-performing regulatory teams and fostering a culture of regulatory excellence.
  • Strategic and Analytical Thinking – A forward-thinking leader who can balance regulatory requirements with business growth objectives and market expansion.
  • Passion for Healthcare Innovation – A commitment to advancing medical technologies while ensuring safety, efficacy, and compliance with global regulations.

Why This Opportunity Stands Out

This role offers a unique opportunity to lead regulatory affairs at a high-growth medical device company while shaping the future of healthcare innovation. As the Chief Regulatory Officer (Med Device) in Irvine, CA, you will:

  • Be a Key Decision-Maker in a Fast-Growing Organization – Take on a senior leadership role where your regulatory expertise directly impacts product development, approvals, and market success.
  • Shape Regulatory Strategy for Cutting-Edge Medical Devices – Work with innovative technologies that have the potential to transform patient care and healthcare solutions.
  • Engage with Global Regulatory Bodies – Gain exposure to international regulatory landscapes, collaborating with FDA, EMA, and other global health authorities.
  • Competitive Compensation & Benefits – Enjoy a lucrative salary, performance-based incentives, and executive-level benefits.
  • Influence Industry Standards – Play a role in shaping regulatory policies, participating in industry discussions, and driving compliance best practices.
  • Work in a Collaborative and Innovative Culture – Join a team dedicated to pushing boundaries in medical device development while maintaining the highest regulatory standards.

FAQs About the Role

Q: What industries should I have experience in?
A: You should have a strong background in the medical device industry, specifically in regulatory affairs, compliance, and product approval processes. Experience with FDA, EU MDR, and ISO regulations is essential.

Q: Is relocation required for this position?
A: The role is based in Irvine, CA. Candidates must be open to relocation or already reside in the area.

Q: What is the reporting structure for this role?
A: The Chief Regulatory Officer (Med Device) in Irvine, CA will report directly to the CEO and collaborate closely with the R&D, clinical, and quality teams.

Q: What kind of leadership style is expected?
A: We seek a strategic, detail-oriented, and proactive leader who can drive regulatory initiatives, mentor teams, and influence cross-functional collaboration.

Q: What is the expected travel requirement?
A: This role may require some domestic and international travel to meet with regulatory agencies, attend industry conferences, and oversee compliance efforts.

Q: What qualifications and skills are required?
A: Candidates should have a bachelor’s or master’s degree in regulatory affairs, biomedical engineering, life sciences, or a related field. A minimum of 10+ years of senior regulatory leadership experience in the medical device sector is required.

Q: How does this role contribute to the company’s overall success?
A: The Chief Regulatory Officer (Med Device) in Irvine, CA is critical to ensuring product approvals, maintaining compliance, and driving regulatory strategies that support market expansion and business growth.

Q: What is the timeline for hiring and onboarding?
A: The company is actively seeking the right candidate and aims to complete the hiring process within the next 60–90 days. Onboarding will include deep dives into current regulatory strategies, introductions to key stakeholders, and alignment on compliance goals.

What Remuneration Can You Expect from This Job?

As the Chief Regulatory Officer (Med Device) in Irvine, CA, you can expect a highly competitive compensation package that reflects your executive leadership role and impact on regulatory strategy. The base salary for this position typically ranges between $250,000 – $350,000 per year, depending on experience, industry expertise, and a track record of successful regulatory approvals.

In addition to the base salary, this position offers performance-based incentives linked to key regulatory milestones, product approvals, and global market expansion efforts. Equity options or stock grants may also be available, offering a stake in the company’s long-term success.

The comprehensive benefits package includes healthcare coverage (medical, dental, and vision), a 401(k) retirement plan with company matching, executive-level performance bonuses, paid time off, and professional development opportunities. Additional perks may include relocation assistance, travel allowances, and participation in key industry conferences.

This role presents a rare opportunity to lead regulatory affairs at an innovative medical device company while securing a lucrative financial package. If you have a passion for shaping regulatory strategy and ensuring compliance in a fast-growing organization, this position offers an exceptional career trajectory.

How to Apply for This Chief Regulatory Officer (Med Device) Position in Irvine, CA

If you are a strategic regulatory leader with a deep understanding of medical device compliance, regulatory submissions, and global market expansion, we invite you to apply for the Chief Regulatory Officer (Med Device) in Irvine, CA. This is an outstanding opportunity to shape the regulatory landscape of a high-growth medical device company.

To apply, please submit your resume and a cover letter detailing your experience in regulatory strategy, FDA and global submissions, compliance leadership, and risk management.

This role offers a rewarding opportunity to lead a top-tier regulatory team, navigate complex regulatory environments, and contribute to the success of groundbreaking medical technologies. Apply today to take the next step in your executive career as a Chief Regulatory Officer (Med Device) in Irvine, CA!

For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.

Chief Regulatory Officer | Medical Device Regulatory | FDA Compliance | Regulatory Strategy | Healthcare Leadership | Risk Management | Regulatory Affairs Executive

Job Category: Chief Regulatory Officer
Job Type: Full Time
Job Location: Irvine

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