Quality and Regulatory Affairs Lead

Amphenol CMT - Critical Medical Technologies; Tijuana; Presencial; MXN 918,000 - 1,286,000; Jornada completa

Descripción de la vacante

A medical technology company in Tijuana seeks a Regulatory Affairs Specialist to develop regulatory plans, manage quality systems, and ensure compliance with international standards. The ideal candidate has a Bachelor's degree in Engineering and 3-5 years of experience in medical device manufacturing. The role includes managing audits and maintaining regulatory submissions. Competitive compensation and growth opportunities are provided.

Formación

• 3-5 years of experience in medical device manufacturing processes.
• Certification desirable (Green Belt, Certified Lead Auditor, or related).
• Knowledge of QSR/JPAL/CE Mark requirements.

Responsabilidades

• Develop and coordinate regulatory plans for compliance.
• File and maintain regulatory submissions for facility registrations.
• Manage internal, external, and supplier audits.

Conocimientos

Leadership skills

Advance Computer skills

Knowledge of National and International Medical Manufacturing Quality Standards

Risk Management analysis

ISO 13485 certified internal auditor

Educación

Bachelor’s Degree in Engineering

Herramientas

Minitab

Microsoft Office

Statistical Software

Descripción del empleo

• Develop and coordinate regulatory plans with full implementation of new and modified products.
• Surveillance of the compliance of the Quality Management System.
• Suggests and implements measures to improve QMS performance.
• Coordinate regulatory research to support regulatory submissions and regulatory advice.
• Coordinate and prepare regulatory information, including 510ks, technical Files and others (as applicable) to compliant with international regulation.
• Review engineering changes (as applicable) to support regulatory compliance.
• File, update, and maintain regulatory submissions in accordance with current US and foreign regulations for facility registrations, certifications, and licenses.
• Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.
• Develop, implement, and maintain the Quality Management System that apply to the activities that occur to be following international regulation.
• Manage Document Control area and assign task and responsibilities including but not limited to resources and priorities.
• Manage and coordinate internal, external and supplier audits to follow national and international regulation. Participate in the performance of the environmental management system in accordance with current roles and responsibilities.
• Coordination of calibration activities.
• Issue and monitoring Customer Complaints, CAPAs, NCMRs.
• Review and issue Hazzard Substances certificates.
• Audit our systems based on standards requirements.
• Manages and supervises quality control and training reports for proper follow-up.
• Set and track quality assurance goals.
• Coordinate with internal / external quality assurance auditors to ensure legal compliance.
• Work with internal teams to increase customer satisfaction by improving the quality of
• the products.

EDUCATION and/or EXPERIENCE

• Bachelor’s Degree in Engineering (industrial, chemical, mechanical, or related).
• Ideal to have 3-5 years of experience in medical device manufacturing processes.
• ISO 13485 certified internal auditor.
• Knowledge QSR/JPAL/CE Mark requirements
• Risk Management analysis.
• Advance Computer skills (Minitab, Office, Word, Excel, Power Point, and/or Application Programs, Statistical Software, Databases. Etc.).
• Ideal to have advanced training skills.
• Knowledge of National and International Medical Manufacturing Quality Standards.
• Certification Desirable (Green Belt, Certified Lead Auditor, Certified Quality Engineer, or any other related.)
• Knowledge of ISO 14001 Environmental management System .
• Leadership skills.

SUPERVISOR RESPONSIBILITIES

• Manages the payroll of assigned team (attendance and punctuality)
• Manages discipline of assigned team (reporting to HR any faults to code of conduct or internal rules code)
• Responsible for the training on job to perform and quality system mandatory requirements of
• training for the assigned team.
• Manages performance of current position and administrates performance reviews and career path for the assigned team.