Regulatory Compliance Specialist

18 hours ago

Sydney, New South Wales, Australia beBeeCompliance Full time

Job Title: Regulatory Compliance Specialist

About the Role:

The Regulatory Compliance Specialist plays a vital role in ensuring the company's products meet regulatory requirements and are compliant with post-market regulations. This role is responsible for coordinating regulatory responses to post-market events, preparing and managing submissions, and maintaining traceability across regulatory reports.

Key Responsibilities:

  • Postmarket Regulatory Leadership: Lead and coordinate regulatory responses to post-market events (FSCAs, recalls), draft, review, and report to regulatory health authorities (FDA, TGA, EU Notified Bodies, Health Canada, and others).
  • Global Compliance & Regulatory Submission: Prepare, submit, and manage postmarket regulatory submissions and notifications, maintain traceability across regulatory reports, monitor submission progress, and support follow-up actions and corrective actions.
  • Risk Analysis & Regulatory Strategy: Contribute to cross-functional postmarket risk assessments, linking complaint data, regulatory trends, and findings, interpret evolving postmarket regulations and standards (e.g., EU MDR Chapter VII, ISO 13485, ISO 20416, MDSAP), provide strategic guidance to stakeholders on regulatory implications of corrective actions and emerging data.
  • Cross-Functional Collaboration & Audit Readiness: Represent RA in postmarket forums and cross-functional teams, support audit readiness by ensuring documentation and processes meet regulatory requirements, partner with RA, Quality, Clinical, and Regional teams to drive alignment in postmarket processes.

Required Skills and Qualifications:

This role requires a bachelor's degree in biomedical engineering, life sciences, or a related field, and minimum 6 years of experience in Regulatory Affairs or Quality Assurance in a regulated medical device environment. Demonstrated expertise in postmarket regulatory functions, including vigilance reporting, complaint handling, and FSCAs, strong technical writing and documentation skills, with attention to regulatory accuracy and detail, and proven ability to work cross-functionally on risk, complaints, or field actions.

Benefits:

Joining this team means working in a collaborative environment where patient safety, product quality, and regulatory soundness must be balanced with business needs. As a Regulatory Compliance Specialist, you will bring calm clarity to urgency, structure to complexity, and be trusted to guide decisions that protect the company's license to operate.

Others:

This role offers opportunities for growth and development in a dynamic and innovative environment, where you will have the chance to contribute to process improvements and special projects across Regulatory Affairs.

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