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Regulatory Compliance Specialist

2 weeks ago


Cork, Cork, Ireland beBeeCompliance Full time
Regulatory Compliance Specialist

McKesson Medical Surgical seeks a highly detail-oriented Regulatory Compliance Specialist to support regulatory compliance activities for private label medical products. This role will focus on reviewing and ensuring labelling compliance, providing operational and administrative support to the Regulatory Monitoring Specialist, and contributing to the continuous improvement of regulatory processes.

Key Responsibilities:
  • Review product labelling to ensure compliance with applicable regulatory requirements.
  • Maintain and update labelling documentation and records.
  • Collaborate with cross-functional teams to ensure timely and accurate labelling updates.
Regulatory Monitoring Support:
  • Assist in tracking and interpreting regulatory changes relevant to McKesson Brands.
  • Support the implementation of regulatory updates into internal procedures and documentation.
  • Help prepare documentation for internal audits and regulatory inspections.
Documentation and Reporting:
  • Maintain regulatory files and databases to ensure audit readiness.
  • Assist in the preparation of regulatory reports and summaries.
  • Support the development and revision of SOPs related to labelling and regulatory monitoring.
Cross-Functional Collaboration:
  • Liaise with internal stakeholders to gather information and ensure alignment on regulatory requirements.
  • Participate in team meetings and contribute to regulatory strategy discussions.
Required Skills and Qualifications:
  • Bachelor's degree in a scientific, engineering, or regulatory discipline.
  • Minimum 2+ years of experience in regulatory affairs, preferably in the medical device or healthcare industry.
  • Familiarity with FDA regulations (21 CFR), ISO 13485, and EU MDR is an advantage.
Benefits:

At McKesson Medical Surgical, we prioritize our employees' physical, mental, and financial well-being through our Total Rewards package. This includes comprehensive benefits to support overall health and wellness.

Others:

We value your ability to manage multiple tasks and deadlines in a fast-paced environment. If you are a detail-oriented professional looking to grow your career in regulatory compliance, please apply for this opportunity.