Regulatory Affairs Associate

The Company

Our client is a Perth-based health technology company that has developed proprietary medical device technology is growing and seeks to expand its capability in the quality, regulatory and scientific areas.

The Role

This full-time role will report directly to the Quality and Regulatory Affairs Manager and will be responsible for assisting with the regulatory functions within the organisation.

This is a full-time, onsite role.

Duties and Responsibilities

• Assist with writing and managing regulatory submissions to relevant regulatory authorities, including the TGA and FDA.
• Assist with the maintenance of existing global registrations. 
• Provide Regulatory reports where required.
• Assist with the preparation and maintenance of Technical product files.
• Keep up-to-date with applicable legal and regulatory compliance requirements globally.
• Stay abreast of any updated regulatory requirements within relevant jurisdictions.
• Work closely with senior management, particularly when entering new markets, to provide regulatory assistance in relation to the design and development of the company’s products.
• Work with senior management to define and direct implementation of internal controls that impact regulatory compliance.
• Support post-market activities for product compliance.
• Interact with certification auditors and regulatory authorities.
• Assist with the scientific development of existing and pipeline products.
• Take an active role in the Quality Management System, assisting with documentation, maintaining QMS accreditation and QC checking.

Qualifications and Skills

• Ideally a Tertiary degree in a biomedical science (or related) discipline.
• At least 2 years experience in Regulatory Affairs, preferably gained in the medical device industry.
• Experience in writing regulatory submissions for various regulatory authorities, including the TGA and FDA.
• An analytical approach and the ability to provide practical solutions. 
• Ability to work on your own initiative, reach decisions and work under pressure.
• Excellent written English.
• Attention to detail.

To Apply

This is an exciting opportunity to make your mark in a growing company.

To apply for this role, please email your CV and a cover letter to *****@biotechrecruitment.com.au.  Confidential enquiries should be made to Dr Janet Preuss via the above email, or on 1800 BIO JOB (1800 246 562).