Regulatory Associate

Cylite Pty Ltd
Melbourne • Eastern Suburbs
Pharmaceuticals & Medical Devices (Healthcare & Medical)
Full time
Posted 14d ago

Cylite is an exciting, fast-growing and award winning start-up company developing innovative optical imaging technologies and medical devices. The company is based in Melbourne, Australia. We are looking for an enthusiastic and established Regulatory Associate.

The Regulatory Associate supports the effective implementation of regulatory strategy and maintenance of life-cycle regulatory compliance to meet Cylite’s marketing and regulatory objectives in various markets/jurisdictions.  

 

Main duties

  • Maintain the technical documentations to ensure its validity in accordance with product status and its compliance with applicable regulatory requirements
  • Lead or support the regulatory dossier preparations and submissions for regulatory clearance
  • Maintain up-to-date awareness of regulatory trends, changes and requirements
  • Identify, track, interpret and communicate global regulatory requirements for product registrations
  • Review current processes for potential improvement and compliance with global regulatory frameworks
  • Review regulatory compliance and assess impact in management of the changes in engineering, supplier/component/material, production process and regulation to ensure continuous compliance
  • Review regulatory compliance and assess impact in the quality management processes such as CAPA and NCR
  • Support the post-market surveillance, review and determine the reportability of customer complaints and adverse events
  • Write and/or contribute to regulatory and safety reports as required
  • Contribute to the development of SOPs, testing protocols, testing reports and project documentation as required
  • Participate and support risk assessments
  • Participate and support regulatory and business-related projects
  • Managing expectations of commercial operations with the expectations of the manufacturing and supply chain
  • Liaise with Quality, R&D, production, manufacturing, sales/marketing in relation to documentation
  • Liaise with external stakeholders such as regulatory authorities, notified bodies, customers, authorised representatives and distributors

 

Background and experience

  • A science or engineering degree of biology, medicine, optics, electronics, mechanics, or the similar discipline. 
  • Minimal 3 years of experience in a regulatory role in medical device or pharmaceutical sector. The regulatory experience in other highly regulated industries may be considered. 
  • Work experience in an organisation certified under ISO 13485 or the similar QMS standard is an expectation.
  • Sound knowledge of global regulatory environment such as the TGA, MDD/MDR, US FDA/21CFR, Health Canada, PMDA, AVISA, NMPA, RoHS, REACH
  • Experience in ISO 14971, IEC 60601, IEC 62304, IEC 62366, ISO 15004 and/or ISO 14155 is highly regarded.
  • Proficient Microsoft Office skill is required

 

Attributes:

  • Good attention to detail.
  • Initiative, proactive, collaborative, responsible, with ownership
  • Willing to work in a fast-paced environment with commitment to meet deadlines.
  • Effective planning and prioritisation skills
  • Good oral and written communication skills
  • Excellent analytical, written and verbal communication and presentation skills as well as the ability to understand technical concepts and requirements of end users
  • Working and communicating effectively across countries and cultures

Employer questions

Your application will include the following questions:
  • Have you worked in a role where you were responsible for authoring and reviewing technical documentation?
  • Which of the following statements best describes your right to work in Australia?
  • How many years' experience do you have as a Regulatory Associate?

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