Director of Quality & Regulatory Affairs-Contract Manufacturing

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

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

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.

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.