Associate Director, Regulatory Affairs and Quality Assurance
Associate Director, Regulatory Affairs and Quality Assurance Posted: 25/02/2025 Closing Date: 28/03/2025 Job Type: Permanent... more info
Quality Assurance and Regulatory Affairs Manager
Salary:
125.00 - 150.00
Posted:
06-03-2025
Category:
Compliance Regulatory Affairs
Perth,
Job Description
Quality Assurance and Regulatory Affairs Manager Our client is a young and growing medical device company located in Perth, Australia. The company currently has an excellent opportunity for a talented and experienced individual to join their executive team as a Quality Assurance and Regulatory Affairs Manager. You’ll be joining a fun and flexible environment where they like to kick goals! You will lead the charge as the company establishes their Quality Management System, prepares for ISO certifications, and builds the dossiers required for regulatory clearances in multiple regulatory jurisdictions. In doing so, you’ll work closely with the team at all levels, championing the importance of quality underpinning everything they do, as well as continuously identifying opportunities to streamline processes where possible. This key management role reports directly to the CEO and has responsibilities for the management of the Quality Assurance and Regulatory Affairs activities. Key Responsibilities of the role include: Drive implementation, adoption, and improvements to the Quality Management System; Liaise with regulatory bodies and other experts to establish the company’s regulatory blueprint; Prepare the Company for quality accreditations (such as ISO 13485 and MDSAP). To be considered as a candidate for this role, you will need to possess the following skills and experience: Quality Assurance management experience in a medical device environment. Experience in compiling medical device regulatory submissions to the TGA, US FDA, and EMA. At least 5 years relevant experience, with a minimum of 3 years senior management experience. Quality assurance auditing experience. Excellent attention to detail. Superior analytical skills. Excellent leadership, organisation, and coordination skills. Fluency in spoken and written English. Tertiary qualification in a biomedical, engineering, or other relevant discipline. 5+ years experience in Software as a Medical Device (SaMD). Experience in teaching or mentoring. If you are interested in a new and exciting career move and you feel you meet the requirements for the role, please send your CV and a cover letter to (emailprotected) so that we can arrange a confidential discussion about this role. #J-18808-Ljbffr
Job Details
Salary: 125.00 - 150.00
Posted: 06-03-2025
Category: Compliance Regulatory Affairs
Perth,
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