STAFF REGULATORY COMPLIANCE SPECIALIST

Johnson & Johnson; Ciudad Juárez; Presencial; MXN 400,000 - 600,000; Jornada completa

Descripción de la vacante

A leading medical device company is seeking a STAFF REGULATORY COMPLIANCE SPECIALIST in Ciudad Juárez. This role involves conducting compliance audits, ensuring adherence to government regulations, and advising on compliance standards. Ideal candidates hold a BS in a relevant field with at least 6 years of experience, preferably in the medical devices or pharmaceuticals sector. The position demands strong analytical and communication skills in both English and Spanish.

Formación

• Minimum 6 years in Quality, Regulatory Compliance, or related fields.
• Experience in Medical Devices or Pharmaceuticals preferred.
• Lead auditor certification is preferred.

Responsabilidades

• Conducts audits—planned and unplanned—to verify compliance with government regulations.
• Provides guidance or advice on compliance with standards and regulations.
• Documents audit results and monitors the effectiveness of corrective actions.

Conocimientos

Effective communication skills in English and Spanish

Analytical skills

Leadership ability

Educación

BS in science, engineering, or business

MBA or Master’s preferred

Descripción del empleo

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Legal & Compliance

Job Sub Function:

Enterprise Compliance

Job Category:

Professional

All Job Posting Locations:

Ciudad Juarez, Chihuahua, Mexico

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

About Cardiovascular

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for STAFF REGULATORY COMPLIANCE SPECIALIST to be in Cd. Juarez, in plant Salvarcar

Purpose:

Conducts audits— planned and unplanned — to verify compliance with government regulations and applicable standards, in addition to company policies and procedures. Give guidance or advice to the organization as it relates to compliance, when required.

You will be responsible for :

• Ensuring Quality System Audits comply with the requirements of QSR/GMP and ISO Standards
• Conducting internal audits of the Quality System for verifying compliance with regulations and standards, including GLP audits as required.
• Providing guidance or advice on compliance with standards and regulations.
• Performing re-audits and implementing corrective and preventive actions.
• Documenting audit results and monitoring the effectiveness of corrective actions.
• Leading audit teams when necessary.
• Reviewing responses to audit observations and advising on responses.
• Maintaining audit documentation.
• Accompanying external auditors and participating in audits at other J&J sites.
• Communicating compliance metrics and participating in regulatory policy formulation.
• Staying updated on regulations and standards.
• Communicating issues and opportunities to management.
• Ensuring compliance with health, safety, and environmental guidelines.
• Performing other duties as assigned.

Qualifications / Requirements:

BS in science, engineering, or business; MBA or Master’s preferred. Minimum 6 years in Quality, Regulatory Compliance, or related fields. Experience in Medical Devices or Pharmaceuticals preferred.

Effective communication skills in English and Spanish. Analytical skills, leadership ability, and knowledge of quality management principles are required. Lead auditor certification is preferred.