Global Product Compliance Specialist

1 week ago

Sydney, New South Wales, Australia Bebeeregulatory Full time

Post-Market Regulatory Consultant
We are seeking a highly skilled Regulatory Affairs professional to support our Post-Market Compliance efforts on a short-term, part-time basis during a critical period for the team. This is an excellent opportunity to contribute meaningfully to our mission by ensuring continued product compliance across global markets.
About the Role
Represent Regulatory Affairs on selected post-market cross-functional teams to ensure effective collaboration and alignment with key stakeholders.
Prepare and implement post-market regulatory assessments to identify potential risks and opportunities.
Support medical device reporting (MDR) and post-market surveillance activities to maintain high-quality data and ensure compliance.
Monitor updates to global regulatory standards and ensure alignment with our existing processes and procedures.
Key Requirements
A degree in Engineering, Science, or a related field, preferably with a focus on Regulatory Affairs.
6+ years' experience in medical device regulatory affairs, with a strong background in post-market activities.
Hands-on experience with regulatory submissions, including preparation of technical documents and responses to inquiries.
Excellent documentation, organizational, and stakeholder communication skills to effectively manage multiple projects and prioritize tasks.
Favorable Qualifications
Familiarity with EU MDR post-market surveillance and ISO 13485 to ensure alignment with industry best practices.
Experience working across multiple global markets, including the US FDA, TGA, and EU, to leverage expertise and knowledge.

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