Regulatory Affairs / Compliance Specialist
Address: Circuito San Jorge 3538 Interior 9,
Parque Industrial San Jorge,
Tlajomulco de Zuñiga, Jalisco, Mexico 45678

Summary:
Regulatory Affairs Specialist performs reviews and audits of certification related documentation, ensuring compliance to all quality management standards, governmental rules, regulations and requirements for the contract manufacturing of products. Fosters divisional teamwork within a continuous improvement environment. Provides regulatory and quality systems support for manufacturing, operations and product development.

Responsibilities:

- Participates and contributes to regulatory departmental management meetings and goal accomplishment
- Serves as customer team liaison for customer audits/questions related to specification requirements
- Monitors and report on key quality and performance indicators as related to regulatory system conformance
- Actively participates in continuous improvement initiatives
- Reviews applicable procedures and work instructions/forms supporting quality system regulation processes for compliance with requirements
- Participating with customer teams, supporting NPI and ongoing production needs related to regulatory requirements
- Recommend new or revised metrics to better qualify/quantify performance
- May give direction and leadership to lower level employees
- Provide regulatory product support including review of change plans, CAPAs and documentation for changes requiring regulatory body approval,



and post-market requirements
- Lead CAPAs and support the CAPA management process through activities such as verification of effectiveness
- Maintain internal audit requirements checklists, ensuring that applicable standards are utilized and updated as revisions are introduced

Required Skills:

- Ability to interpret, understand, and apply regulatory requirements and quality management standards as applicable to assigned customers, projects and/or products
- Capable of performing timely and accurate review of MRR and MRR waiver submittal
- Capable of performing timely and accurate review of validations such as IQ, OQ and PQ documentation
- Demonstrate effective customer interface skills
- Knowledge of ISO quality management standards and other standards related to business sectors that support customers’ needs/products; electronic device contract manufacturing preferred
- 4-year College Degree or equivalent combination of education and experience as approved by executive management
- 5+ years of regulatory experience with moderate to complex key customers
- Demonstrate the ability to interpret and communicate moderately complicated quality system regulations

Ubicación geográfica: Jalisco: Tlajomulco de Zúñiga

Horario de trabajo: 0800-1700 M-F

Full Time

Más información sobre Benchmark Mexico: https://linktr.ee/benchmarkmx

Job Types: Full-time, Permanent

Pay: $192,488.00 - $449,138.00 per week

Work Location: In person

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