Director, Regulatory Compliance
$150,000–$258,750 year
On-siteIrvine, California, United States
Job Summary
Lead tactical and strategic compliance support for the Cardiovascular Segment's worldwide headquarters, manufacturing, and R&D sites. Conduct follow-up activities for independent audits, field assessments, and health authority inspections while ensuring inspection readiness at high-risk locations. Analyze compliance risk profiles using metrics and intelligence to proactively identify, prioritize, and mitigate risks through risk-based action plans. Provide independent evaluation of compliance trends, interpret audit observations, and guide cross-regional remediation strategies. Serve as a key advisor for due diligence, mock inspections, and regulatory agency interactions, ensuring alignment with global regulatory requirements and emerging industry trends.
Required Qualifications
- A minimum of a BS
- A focused degree in science, engineering, or equivalent
- A minimum of 10 years of progressive experience in the pharmaceutical/medical device/biotech industry
- Significant experience in managing all aspects of Quality and Regulatory Compliance in an international, global context, in a regulated healthcare environment
- Expert and broad-based knowledge of Quality System regulations, ISO, ICH, PIC/S, and GMP regulations
- Experience performing GXP audits
- Experience effectively interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc.
- Ability to resolve complex regulatory compliance issues
- Ability to analyze and interpret scientific and technical journals, and legal documents
- Proven success in strategy development and project management, building consensus across broad geographies and business segments
- Excellent written and oral communication skills, including proven ability to make technical and complex topics clear and easily understood
- Ability to effectively present information to executive management
- Ability to drive successful program management and build strong cross-functional relationships
- Ability to influence, negotiate, and build credibility to enable achievement of mutual goals
- Strong skills in interdependent partnering to facilitate collaboration
- Ability to perform work independently and proven experience in driving progress and remaining focused under ambiguous and complex situations
- This position may require 40 to 50% of domestic and/or international travel
Desired Qualifications
- A focused degree in science, engineering, or equivalent is highly preferred
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