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Regulatory Affairs Associate

Employer
i-Pharm Consulting
Location
Australia, Melbourne, Victoria
Salary
AUD75000.00 - AUD90000.00 per annum
Start date
11 Aug 2022
Closing date
25 Aug 2022

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

ROLE/RESPONSIBILITIES

  • Maintain technical documentations to ensure compliance with regulatory requirements
  • Regulatory dossier preparations and submissions for regulatory clearance
  • Remain up-to-date with regulatory trends, changes and requirements, and communicate these requirements to team members
  • Review processes for improvement and compliance with regulatory frameworks
  • Ensure regulatory compliance across engineering/supplier/component/material/production process
  • Assess impact of regulatory changes in the quality management processes such as CAPA and NCR
  • Support the post-market surveillance, review and report customer complaints and adverse events
  • Write or contribute to regulatory and safety reports as required
  • Contribute to the development of SOPs, testing protocols, testing reports and project documentation
  • Participate and support risk assessments, as well as regulatory and business-related projects
  • Managing expectations of commercial operations when working with 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

REQUIREMENTS

  • A science or engineering degree
  • Minimum 3 years experience in a pharmaceutical or medical device regulatory affairs position
  • Global regulatory submissions and ISO13485 experience is beneficial

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, Los Angeles and San Diego. In a highly competitive market-place, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

Find Us
Website
Telephone
+44 (0) 20 3189 2299
Location
22 Long Acre
London
England
WC2E 9LY
United Kingdom
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