Regulatory Affairs Associate
vor 3 Wochen
Regulatory Affairs Associate - 1 year FTC Join a leading global healthcare company as a Regulatory Affairs Associate (1 year FTC).
In this role you will assist the Regulatory Affairs team with the review of all existing Medical Device registrations and new product registrations for Australia and New Zealand.
The role will include evaluation, submission, tracking, and follow-up submissions.
Key Responsibilities:
Assisting in aligning current regulatory strategies for the organisation.
Review & maintenance of existing product registrations for medical devices, pharmaceuticals with the companies portfolio (medicine & medical device and cosmetic management).
Recognising adverse events, recording these and reporting to the Senior RA Manager.
Assist with establishment and coordination of relevant legislative, regulatory, contractual and other compliance procedures.
Knowledge, Skills & Experience:
Bachelors degree in Pharmacy, Science, Engineering or related field.
Minimum 2+ years regulatory experience in the healthcare industry in the field of medical devices or pharmaceuticals.
Knowledge and experience across TGA & Medsafe regulations.
Strong understanding of regulatory requirements and guidelines for medical devices and prescription medicines across multiple regions.
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