Senior QA RA Officer, Whyte Medical. Sydney NSW. Pharmaceuticals & Medical Devices (Healthcare & Medical). Full time. Competitive salary package.

Company Overview: Innovative NeuroTech Company is in an exciting growth phase. newly created role in the Sydney team. Unique opportunity to sink your teeth into an exciting project and truly make an impact. As part of the pioneering NeuroTech SaMD company, you will be contributing to groundbreaking advancements in brain health and safety. Secure role and company with career development opportunities

Role Overview: We are seeking a Senior QA/RA Officer. Based in Sydney, this pivotal role will focus on navigating FDA and TGA submissions and regulations and leading future QA/RA projects.

Key Responsibilities: Lead the transition from design and verification to validation in compliance with FDA and TGA regulations. Oversee ongoing projects to ensure adherence to QA/RA standards. Conduct detailed auditing assessments to identify and rectify any non-compliance issues. Develop and implement robust QA/RA procedures. This is a small team, so this is a great opportunity for someone who wants to pave the way for the QA/RA division.

Benefits: Competitive salary package (negotiable based on relevant experience). WFH 2 days a week. Be part of the company's exciting growth trajectory and contribute to its success. Work with the Exec Management team—a nimble business that is able to make quick decisions. Secure business that can offer future career development opportunities.

Skills and Qualifications Required: 4+ years of experience in a QA/RA role. Medical Device industry experience is a must-have. Solid knowledge of FDA and TGA regulations. Auditing experience. Proficiency in design verification and validation processes. Excellent communication skills: add value and be a friendly, professional member of the team. I am able to get to the Sydney CBD office 3 days a week. Australian Citizen or PR. Passion for QA/RA and, ideally, a genuine interest in Medical Devices/SaMD.

If you meet the above qualifications, we invite you to apply!

Send your CV via the prompts.

NOTE: Never make payment to any employer, person, company, contractor or agency to get hired for a Job.

For a discussion, contact Lucie Whyte 0468602482 or lucie@whytemedical.com.au