Regulatory Affairs & Quality Specialist II

Location: Circuito San Jorge 3538 Interior 9, Parque Industrial San Jorge, Tlajomulco de Zúñiga, Jalisco, México 45678

Hours: 8:00 a.m. to 5:00 p.m. Monday through Friday
Pay Range: $31,342.78 MXN a $35,260.63 MXN / month

Position Summary

The Regulatory Affairs & Quality Specialist is responsible for supporting regulatory compliance and quality management system (QMS) activities within an FDA-regulated electronic medical device manufacturing environment. This role ensures compliance with FDA 21 CFR Part 820, ISO 13485, customer requirements, and applicable international regulations governing the design, manufacture, and distribution of medical devices. The specialist partners closely with Manufacturing, Engineering, Quality, Supply Chain, and Product Development teams to support new product introductions (NPI), production operations, validation activities, audits, and continuous improvement initiatives. This position serves as a primary liaison for customers, notified bodies, and regulatory agencies regarding quality and regulatory compliance matters.

Key Competencies

- FDA 21 CFR Part 820
- ISO 13485 Quality Management Systems
- CAPA Management
- Internal & External Auditing
- Validation (IQ/OQ/PQ)
- Change Control
- Nonconformance Management
- Root Cause Analysis
- New Product Introduction (NPI)
- Electronic Device Manufacturing
- Customer and Regulatory Agency Interaction
- Continuous Improvement

Key Responsibilities

- Support and maintain compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable electronic device regulations and standards.
- Provide regulatory and quality systems support for electronic medical device manufacturing operations, engineering, and new product introduction programs.




- Serve as the primary customer-facing regulatory contact for audits, compliance inquiries, quality documentation reviews, and specification requirements.
- Review and approve quality system documentation, including procedures, work instructions, manufacturing records, validation protocols, and quality agreements.
- Support product transfers, design changes, engineering change orders (ECOs), and manufacturing process changes to ensure regulatory compliance.
- Review and assess change control documentation and determine regulatory impact for design, process, supplier, and manufacturing changes.
- Lead and facilitate Corrective and Preventive Action (CAPA) investigations, root cause analysis, implementation activities, and effectiveness verification.
- Review and approve nonconforming material reports (MRRs), deviations, waivers, and related quality documentation.
- Support validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.
- Participate in risk management activities in accordance with applicable medical device requirements.
- Develop, maintain, and monitor quality and regulatory performance metrics and report trends to management.
- Coordinate and manage internal audits, customer audits, supplier audits, and third-party certification audits.
- Maintain audit readiness and support FDA inspections,



notified body audits, and customer assessments.

Required Qualifications

- Advanced English proficiency (CEFR C1 or higher), with the ability to prepare technical documentation, support customer and certification audits, and communicate effectively with integral stakeholders.
- Bachelor’s degree in engineering, Quality, Regulatory Affairs, or a related technical discipline; equivalent experience may be considered.
- Minimum 5 years of experience in Regulatory Affairs, Quality Systems, or Quality Assurance within the electronic device manufacturing industry.
- Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, and medical device quality device system requirements.
- Demonstrated experience conducting and managing internal, external, customer, supplier, and certification audits.
- Experience reviewing validation documentation, including IQ, OQ, PQ, software validations, and process validations.
- Knowledge of nonconformance management, CAPA, change control, risk management, and complaint handling processes.
- Ability to review and approve MRRs, deviations, waivers, and other quality records.
- Strong understanding of document control and quality management system requirements.
- Excellent analytical, problem-solving, and root cause investigation skills.

Preferred Certifications

- ISO 13485 Internal Auditor Certification
- ISO 13485 Lead Auditor Certification
- Certified Quality Auditor (CQA)
- ASQ Certified Quality Engineer (CQE)
- Certified Medical Device Auditor (CMDA)
- Regulatory Affairs Certification (RAC)

Job Types: Full-time, Permanent

Pay: $31,342.78 - $35,260.63 per month

Language:

- English at C1 Proficiency or Above (Required)

Work Location: In person

📌 Regulatory Affairs & Quality Specialist II (Tlajomulco de Zúñiga)
🏢 Benchmark Electronics
📍 Tlajomulco de Zúñiga