Regulatory Compliance Specialist

4 weeks ago

Shanghai, Shanghai, China Cardinal Health Full time

About Cardinal Health

Cardinal Health is a leading healthcare company that provides products, services, and solutions to help patients live healthier lives.

Estimated Salary: $120,000 - $180,000 per year

Job Summary:

We are seeking a skilled Regulatory Compliance Specialist to join our Quality Assurance team. In this role, you will be responsible for assessing processes and practices for regulatory risk and conformance to quality standards.

Responsibilities:

  • Conduct thorough Quality Management System, Process, and/or Product audits of all assigned Raw Material, Component, Services or Finished Goods Suppliers
  • Demonstrate comprehensive knowledge of regulatory requirements in their respective areas, as well as auditing techniques
  • Assist in analyzing regulatory requirements and overall program compliance to determine enterprise risk
  • Manage applicable internal corrective actions in response to audit findings to ensure effectiveness and avoid repeat issues
  • Identify and propose audit program enhancements
  • Ensure compliance with regulations and controls by examining and analyzing records, reports, operating practices, and documentation.
  • Communicate best practices observed to other business units.
  • Prepare for audits by researching materials, standards, policies and procedures to formulate a plan of action.
  • Lead the escalation process for unacceptable audits to appropriate management representatives

Accountabilities:

  • Apply experience and knowledge of MDD (Medical Device Directive), EU-MDR (Medical Device Regulations), ISO 13485 (Quality Management Systems), Pharmaceutical guidelines, FDA, cGMP, MDSAP (Medical Device Single Audit Program) and Risk Management (ISO 14971) to instill a culture dedicated to regulatory compliance
  • Knowledge of business platforms and processes such as Veeva Vault, SAP, BPCS and Agile PLM
  • Ability to multi-task and work in a high paced environment with an awareness of continued impact on compliance and operational performance
  • Organized and resourceful with excellent attention to detail and ability to execute on assigned project plans
  • Excellent written and verbal communication skills to drive clear alignment of company and department goals
  • The ability to take responsibility for the professional development of you and your colleagues
  • Commitment to work within the ethos of the company mission, code of conduct and applicable legal standards/regulations

Qualifications:

  • Bachelors in related field preferred, or equivalent work experience, preferred
  • 4+ years of experience in related field, preferred
  • Experience performing Quality System audits in the Medical Device or other regulated industry.
  • Current knowledge of GMP auditing & regulation (FDA 21 CFR 820 & 21 CFR 210/211, & ISO13485) & international quality system requirements
  • Language Skills: Ability to read, analyze and interpret quality system documents, records, and technical procedures.
  • Ability to write reports, business correspondence and procedure manuals.
  • Ability to effectively present information to groups of managers, clients, and the general public.
  • Certificates, Licenses, Registrations: Certified Quality Auditor (CQA) to ASQ CBA, ASQ CQA, or ISO Lead Auditor training by an accredited organization and/or Certified Quality Engineer (CQE) strongly preferred.
  • Up to 50%-70% of travel required.

What We Offer:

  • A competitive salary and benefits package
  • A dynamic and supportive work environment
  • Opportunities for professional growth and development

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