Location: Coyol, Costa Rica (Primary) with oversight of Texas facility.
Position Summary
The Director of Quality and Regulatory Affairs - Contract Manufacturing is responsible for further developing and leading the company's global Quality Management System (QMS) and Regulatory Affairs strategy across contract manufacturing operations in multiple sites across Costa Rica, United States with rapid expansion to other countries. This executive leadership role ensures compliance with all applicable FDA, ISO, EU MDR, international regulatory, and customer requirements while driving a culture of quality, continuous improvement, and operational excellence. This role is critical to ensure our products meet global regulatory requirements while supporting new product development and ongoing operations.
The Director of Quality and Regulatory Affairs - Contract Manufacturing will oversee all quality assurance, quality control, regulatory affairs, supplier quality, post-market surveillance, complaint handling, CAPA, internal auditing, and inspection readiness activities. The ideal candidate is a strategic leader with deep experience navigating FDA regulations, ISO 13485, EU MDR and other international regulatory requirements, and multi-site medical device manufacturing environments.
Because this role provides leadership across facilities in both the United States and Costa Rica and other potential countries, fluency in both English and Spanish is required.
Key Responsibilities
Regulatory Affairs
- Develop and execute the global regulatory strategy for all medical device products
- Ensure compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, MDR, MDSAP, and applicable international regulations
- Lead regulatory submissions including:
- 510(k)
- Technical Files
- Letters to File
- Product Registrations
- International market registrations
- Monitor changes in global regulatory requirements and proactively implement necessary changes
- Serve as the primary liaison with regulatory agencies including FDA, notified bodies, and international regulatory authorities
- Lead FDA inspections and regulatory audits
- Partner with sales team to promote new product development
Quality Management
- Own and continuously improve the company's Quality Management System (QMS)
- Ensure compliance with:
- ISO 13485
- FDA Quality System Regulation
- Good Manufacturing Practices (GMP)
- Internal quality standards
- Establish quality objectives and KPIs across both manufacturing sites
- Lead Management Review meetings
- Oversee document control, change management, and quality system documentation.
Quality Operations
Provide leadership and ownership over:
- Quality Assurance, Nonconformance Management
- Supplier Quality & Onboarding
- Process Validation Support
- Corrective and Preventive Actions (CAPA)
- Post-Market Surveillance and Complaint Handling
- Risk Management
- Audits (Internal, Customer, SGS, FDA, etc)
Operational Leadership
- Partner closely with Operations, Engineering, Manufacturing, Supply Chain, and R&D to ensure quality is integrated into all business processes
- Drive continuous improvement initiatives using Lean Manufacturing, Six Sigma, and/or other project management methodologies
- Establish metrics to improve:
- First Pass Yield
- Cost of Quality
- Supplier Performance
- Customer Quality
- Audit Performance
- Complaint Rates
- Support new product introductions and manufacturing transfers
Leadership
- Build, coach, and develop high-performing quality and regulatory teams across all locations
- Foster a culture of accountability, continuous improvement, and compliance
- Standardize quality processes across multiple facilities
- Mentor future quality leaders within the organization
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related technical discipline
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15+ years or equivalent of progressive experience in quality and regulatory affairs, quality management systems, regulatory compliance, contract manufacturing, supplier quality, quality assurance, and/or quality engineering within the medical device industry, including experience leading quality organizations and supporting complex manufacturing operations.
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8+ years or equivalent of people leadership experience, including leading senior individual contributors and managers on quality and regulatory teams
- Experience supporting multi-site manufacturing operations
- Fluent in both English and Spanish (written and verbal)
- Demonstrated experience leading FDA inspections with successful outcomes
- Extensive knowledge of:
- ISO 13485
- MDSAP
- FDA 21 CFR Part 820
- Risk Management (ISO 14971)
- Design Controls
- CAPA
- Complaint Handling
- Supplier Quality
- Validation
- Experience working with international manufacturing locations.
Preferred Qualifications
- Master's degree in Engineering, Business Administration, or related field
- ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Certified Manager of Quality/Organizational Excellence (CMQ/OE)
- Regulatory Affairs Certification (RAC)
- Lean Six Sigma Green Belt or Black Belt
- Experience with Class II and/or Class III medical devices
- Experience supporting manufacturing operations in Latin America
Travel: Approximately 0-25% domestic and international travel, including regular travel to the US.