Regulatory Affairs Specialist (12 month fixed term contract)

at  McKesson

POSITION SUMMARY:

Reporting to the Director of Quality Assurance, the Regulatory Affairs Specialist will ensure product regulatory compliance for all existing McKesson own brand products where a 510(k) submission was required.

• Ownership of 510(k) summary review of existing McKesson Brand products.
• Reviews all product labelling against 510(k) summary available on file.
• Generate overview report outlining evaluation result per device
• Generate product group reports outlining any discrepancies identified against the 510(k) information and/or product qualification documentation (including definition of product(s) in scope, associated 510(k), identified discrepancies/results, and recommendations for actions.)
• Develop 510(k) review process for new McKesson Brand Projects
• Develop review process for new product qualification activities where the product requires a 510(k)
• Generate or update required SOPs with the new process.
• Provide training to existing product qualification and audit personnel on 510(k) review.
• General QA/RA support
• Supports continuous improvements in regulatory processes, QMS processes and updating Standard Operating Procedures.
• Participates in internal and external audits.
• Completes supplier & product QA activities as required
  At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves.
  As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.