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)
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, and Los Angeles. In a highly competitive marketplace, 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.
For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them.
As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.
We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.
- Website
- http://www.i-pharmconsulting.com/
- Telephone
- +44 (0) 20 3189 2299
- Location
-
52 Bedford Row
London
England
WC1R 4LR
United Kingdom
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