Post-Market Compliance Specialist

2 days ago

Sydney, New South Wales, Australia Bebeeregulatory Full time

About the Role
Improve lives through innovative and connected health solutions as a Regulatory Affairs Consultant on a short-term, part-time basis.
Work across post-market regulatory activities to maintain compliance for marketed medical devices.
Contribute to ensuring continued product compliance across global markets by collaborating with stakeholders on Quality, Product Development, and Global Product Management teams.
Represent Regulatory Affairs on selected cross-functional teams, prepare and implement post-market regulatory assessments, support medical device reporting, and monitor updates to global regulatory standards.
Analytical and experienced regulatory professional needed to:
Deliver key assessments and ongoing product lifecycle activities.
Support business continuity and compliance through special projects.
We're passionate about improving lives and thrive on innovative ideas. Key responsibilities include:
Key Responsibilities:
Post-Market Surveillance
Regulatory Assessments
Medical Device Reporting
Global Regulatory Standards
Requirements include:
6+ years' experience in medical device regulatory affairs.
Familiarity with EU MDR post-market surveillance and ISO 13485.
Ability to quickly adapt and prioritize tasks in a dynamic environment.
We're looking for someone who is passionate about improving lives and can contribute to our mission of improving patient outcomes. The ideal candidate will have strong analytical skills, be able to work independently, and have excellent communication skills.

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