Regulatory Compliance Specialist

1 week ago

Brisbane, Queensland, Australia beBeeRegulatory Full time $96,161 - $118,111

Job Description:

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The primary objective of this role is to support the Regulatory Affairs team with a focus on preparing and maintaining regulatory documentation, ensuring compliance with relevant regulations and standards.

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This position will be responsible for creating and managing Medical Device Files, liaising with cross-functional teams to understand and collate information required for regulatory submissions, and communicating with regulatory agencies and conformity assessment bodies.

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Key responsibilities include preparing and submitting regulatory documentation, maintaining medical device files, and performing administrative tasks such as document formatting and preparation for internal change control processes.

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The ideal candidate will have experience in creating regulatory documentation, working in quality assurance or regulatory affairs within a highly regulated industry, and demonstrating strong analytical skills with innovative thinking.

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Required Skills and Qualifications:

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  • ">
  • Experience in creating regulatory documentation for submission to regulatory authorities">
  • Tertiary qualification in science, engineering, pharmacy or microbiology">
  • Experience in quality assurance or regulatory affairs within a highly regulated industry">
  • Strong analytical skills with innovative thinking">
  • Excellent communication and interpersonal skills">
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Benefits:

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This role offers a stable and global company environment with flexible start and finish times, and flexible work location. It also provides opportunities for professional growth and development.

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Others:

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Cook Medical values diversity and inclusion, and encourages employees to bring their full, authentic selves to work. The company strives to create an environment where employees can feel empowered to make decisions and contribute to improving how they work.

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