Senior Medical Device Safety Specialist

2 weeks ago

Melbourne, Victoria, Australia beBeeRegulatory Full time $135,000 - $150,000
Job Title: Post Market Surveillance Manager

This role is responsible for ensuring the ongoing safety and effectiveness of medical devices.

PMS System & Compliance Management:
  • Manage, maintain, and continuously improve the Post-Market Surveillance system, documentation, and related procedures.
  • Advise on and implement updates to the PMS system based on new or revised regulations, guidance documents, and feedback from Notified Bodies and Competent Authorities.
  • Ensure the PMS plan is executed on schedule, coordinating with cross-functional stakeholders to gather inputs and ensure global compliance.
About the Role:
  • A Bachelor's degree in Bioengineering, Nursing, a related Health Science, Quality, or Regulatory field; an advanced degree (Master's or PhD) is highly preferred.
  • A minimum of 8 years of experience in the medical device or pharmaceutical industry.
  • At least 2 years of dedicated, hands-on experience in Post-Market Surveillance and/or Vigilance is essential.

This position requires strong technical writing and editing skills, with a proven ability to produce clear and accurate documentation. You will also need exceptional interpersonal and communication skills for effective collaboration with internal teams, stakeholders, and Key Opinion Leaders.

We offer a dynamic work environment and the opportunity to contribute to ground-breaking projects that shape the future of the industry.

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