Senior Regulatory Affairs Associate
- Experience Level
- Experienced (non-manager)
The company is a top tier global Medical Device company with an established portfolio of devices spanning across multiple therapeutic areas.
- Support the local Regulatory Affairs (RA) team and liaise closely with international colleagues to prepare and complete regulatory submissions across various regions.
- Provide mentorship to more junior team members and guide them along for regulatory submissions.
- As a representative of the RA team, to liaise with team members on cross functional teams (QA, Engineering, Supply Chain) to ensure successful delivery of projects.
- Prepare and maintaining technical documentation (design and technical dossiers) for device regulatory submissions globally for the company.
- Support the RA managers in the development and execution of the RA Strategy for the company.
- Degree in a relevant discipline (Life Sciences, Engineering, Pharmacy)
- At least 4 years of Regulatory Affairs experience in the Medical Device industry in Australia and New Zealand (experience with Class I, IIa, IIb, III devices)
- Familiarity with EU MDR will be advantageous for the role
- Experience in a medical device manufacturing/engineering design setting will be useful for this role
- Organized individual with a strong eye for detail
- Innovative and collaborative individual
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