Regulatory Compliance Specialist

1 week ago

Sydney, New South Wales, Australia beBeeCompliance Full time $100,000 - $130,000
Job Title: Regulatory Compliance Specialist

We are seeking an experienced Regulatory Compliance Specialist to ensure the company's products meet all regulatory requirements.

About the Role:
  • Key responsibilities include ensuring compliance with relevant regulatory standards and guidelines, monitoring and interpreting changes in regulations, and collaborating with cross-functional teams to gather necessary information for regulatory submissions.
  • The successful candidate will have a Bachelor's degree in a relevant scientific or engineering discipline and proven experience in Regulatory Affairs within the Medical Device sector, with specific exposure to In Vitro Diagnostics (IVDs).

This role involves working collaboratively with internal teams to achieve regulatory goals, providing expert guidance on regulatory matters, and contributing to the development and maintenance of the company's quality management system.

Key Responsibilities:
  • Regulatory Compliance:
    • Ensure compliance with relevant regulatory standards and guidelines.
    • Monitor and interpret changes in regulations.
  • Submission Management:
    • Collaborate with cross-functional teams to gather necessary information for regulatory submissions.
  • Quality System Support:
    • Contribute to the development and maintenance of the company's quality management system.
    • Participate in internal and external audits related to regulatory affairs.
  • Product Lifecycle Management:
    • Support regulatory aspects of product development from concept through commercialisation.
    • Provide regulatory input to product development teams.
  • Communication and Collaboration:
    • Liaise with regulatory authorities, notified bodies, and other relevant stakeholders.
    • Collaborate with internal teams to achieve regulatory goals.

The ideal candidate will possess strong analytical skills, excellent communication skills, and a thorough understanding of regulatory requirements.

Competitive salary and dynamic work environment offered. If you're passionate about regulatory affairs, please submit your application.

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