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Regulatory Compliance Specialist

hace 2 meses

Oaxaca, Oaxaca, México Johnson & Johnson A tiempo completo
Job Summary

We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Johnson & Johnson. As a key member of our organization, you will be responsible for ensuring compliance with government regulations and applicable standards.

Key Responsibilities
  • Conduct audits to verify compliance with government regulations and company policies and procedures.
  • Provide guidance and advice to the organization on compliance matters.
  • Ensure that Quality System Audits comply with QSR/GMP and ISO Standards.
  • Conduct internal audits of the Quality System to verify compliance with government regulations and company policies and procedures.
  • Perform re-audits to deficient aspects and implement corrective and preventive actions as necessary.
  • Assign classifications to internal audit observations and document audit results in written reports.
  • Monitor the effectiveness of corrective actions documented in observation responses.
  • Lead audits as a team lead and provide guidance to auditors.
  • Review ownership of responses to audit observations and provide advice on audit observation responses.
  • Maintain audit report files, re-audit files, and responses to audits carried out.
  • Accompany external auditors, government representatives, and management during audits.
  • Conduct audits at other J&J sites as required.
  • Comply with and review compliance metrics and communicate them to site management and the Franchise.
  • Prepare information for Management review boards.
  • Participate in the formulation of Regulatory Policies and Procedures in compliance with applicable local, state, and federal standards and regulations.
  • Stay up-to-date on government regulations and applicable standard changes through publications, seminars, and collaboration with organizations.
  • Communicate business-related matters and opportunities to the next managerial level.
  • Ensure personal and Company compliance with all Federal, State, and Local company regulations, policies, and procedures.
Requirements
  • BS in science, engineering, or business.
  • MBA or Master's in Science, preferably.
  • Minimum 3 years of experience in Quality, Regulatory Compliance, or related activities and demonstrated performance.
  • Experience in Medical Devices field or in Pharmaceuticals (preferably).
  • Lead Auditor Certification by an accredited organization preferred.
  • Effective communication skills - oral and written - (English and Spanish).
  • Analytical skills to interpret scientific and technical publications and legal documents.
  • Ability to select, manage, and lead a team during an audit.
  • Ability to respond to questions or complaints from clients, regulatory agencies, or members of the business community.
  • Skills to present information effectively to senior management, public groups, and/or directors.
  • Skills to work with mathematical concepts, such as probability and statistical inferences, fundamentals of geometry, and trigonometry.
  • Skills to interpret a variety of instructions presented in writing, verbally, or graphically (diagrams and programs).
  • Skills for the use of computers and associated systems (software).
  • Skills to interact with auditors by the government and independents.