Medical Device Regulatory Compliance Specialist

1 week ago


Sydney, New South Wales, Australia beBeeCompliance Full time $120,000 - $150,000
\Surgical Guide Quality Engineer\

We are seeking a seasoned professional to lead compliance and audit readiness for FDA 510(k) submissions and ISO 13485 audits.

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  • The ideal candidate will have hands-on experience with surgical guides, a proven track record with 510(k) submissions, and strong knowledge of regulatory requirements.
  • They will also possess experience with Class II / implantable devices and an ex-Notified Body auditor background.
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The successful candidate will be responsible for leading compliance activities and audit readiness, utilizing their expertise to support regulatory milestones and collaborate with cross-functional teams.

\Key Responsibilities\
  • Lead compliance activities and audit readiness
  • Support regulatory milestones
  • Collaborate with cross-functional teams
\

This is a unique opportunity to apply your expertise and drive compliance and audit readiness in the medical device industry.



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