Global Regulatory Affairs and Compliance Manager
On-siteAlbuquerque, New Mexico, United States
Job Summary
Develop and execute global regulatory strategies to ensure compliance with FDA, ISO 13485, and international standards across manufacturing operations. Lead site readiness for regulatory inspections and serve as the primary representative during FDA audits, certification body reviews, and customer assessments. Maintain establishment registrations, Drug Master Files, and regulatory documentation while driving continuous improvement initiatives and corrective actions. Partner with cross-functional teams to support product lifecycle management, new product introductions, and technology transfers. Identify compliance risks, develop mitigation strategies, and promote a culture of regulatory excellence.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related technical discipline
- Minimum 3 years of experience in Regulatory Affairs within the medical device industry
- Minimum 6 years of experience in Quality Assurance, Quality Systems or Compliance within the medical device industry
- Minimum of 3 years of experience conducting audits in the medical device industry
- Minimum 3 years of leadership or management experience
- Experience supporting Health Authorities inspections and/or external audits
- Thorough knowledge of: ISO 13485
- Thorough knowledge of FDA Quality Management System Regulation (21 CFR Part 820/QMSR)
- Thorough knowledge of Medical Device Submissions
- Thorough knowledge of ISO 14971
- Thorough knowledge of Global medical device regulatory requirements
- Strong understanding of Quality Management Systems
- Experience with CAPA
- Experience with Nonconforming Product
- Experience with Complaint Handling
- Experience with Risk Management
- Experience with Change Control
- Experience with Internal Audits
- Strong analytical and problem-solving abilities
- Excellent regulatory writing and technical documentation skills
- Effective project management and organizational skills
- Excellent verbal and written communication skills
- Ability to influence cross-functional teams without direct authority
- Proficiency with electronic Quality Management Systems (eQMS)
- Proficiency with document management systems
- Proficiency with Microsoft Office applications
Desired Qualifications
- Master's degree preferred
- Regulatory Affairs Certification (RAC)
- ASQ Certified Quality Auditor (CQA)
- ASQ Certified Quality Engineer (CQE)
- Exemplar Global Lead Auditor (ISO 13485)
- Lean Six Sigma Green Belt or Black Belt (preferred)
- Lead Auditor certification preferred
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