Quality Assurance and Regulatory Affairs Manager
Job No:
119898
Location:
Maryborough
- Unique QA/RA role in the Medical Device industry - enjoy the freedom to design the way you work
- Competitive remuneration package on offer, in line with skill and experience
- Help to write the future of this highly reputable organisation as it enters its most exciting chapter
About the Organisation
Our client is a Brisbane-based public company listed on the Australian Stock Exchange. The company is dedicated to the design, development, and supply of Class I and II medical devices.
Since having recently refined their product offering, they now occupy a confident and focused market position. While firmly committed to the central value of quality, the aim now is to bring their production and operational processes in-house, to ensure control and transparency into the future.
The team is a group of dedicated and adaptable individuals who work cohesively to overcome challenges and identify improvement opportunities.
About the Opportunity
The QA/RA Manager opportunity is a multifaceted, highly practical role that will suit an individual with a proven history of product design, manufacturing and supply chain experience. Success in the role will require you to be discerning and innovative, willing to assess the framework of both existing and proposed operational practices, and able to apply improvements.
More Specifically, your duties will include (but not be limited to);
- Ensuring compliance with the FDA's Quality Systems regulations, GMPs, ISO13485 and other local and international regulatory requirements;
- Participating in root cause analysis and taking corrective and preventive actions for product and process issues, including internal and external audits as necessary;
- Conducting and overseeing internal and external audits;
- Acting as the liaison with regulatory agencies, and internal departments for new product submission strategies, as well as participating in regulatory agency inspections such as pre-approval inspections, quality system inspections, and cGMP inspections.
- Training new staff on quality expectations, promoting a high level of respect for quality and compliance, and briefing the engineering and product development teams on regulatory requirements throughout the design process, and;
- Maintaining up to date and relevant knowledge of FDA, TGA and other local and foreign regulations and promoting an organisation-wide culture of audit-readiness.
This position will continue to evolve commensurately with the company's exciting new operational vision. As such, it will require flexibility and a willingness to take ownership of the duties it comprises in order to establish and maintain reliable efficiency.
About You
This position requires a driven self-starter; someone who can use their initiative to construct their own roadmap for the role, and execute their day to day in accordance with it. The successful candidate will have high attention to detail, strong written and verbal communication skills, and an influential communication style. You will ideally have experience in a leadership role, with demonstrable instances of coaching and leading by example.
Additionally, you must hold the following qualifications and experience:
- A Bachelor’s Degree in Science, Engineering, or Healthcare;
- 5+ years of experience in managing quality assurance/regulatory affairs for medical devices;
- Previous management of a QMS under ISO 13485, and the MDD/MDR for product development and manufacturing in the UK/EU;
- Good working knowledge of US FDA 21 CFR 820 Quality Systems Regulation, and product approval process.
- Experience filing submissions for medical devices in the US and international markets, i.e. 510(k)s, technical files, summary technical documents (STED), and;
- Excellent awareness of Class I and Class II devices.
- Experience with submissions for software-driven medical devices is preferred.
About the Benefits
To attract and keep the right candidate, a highly competitive remuneration package is on offer, in line with qualifications and experience.
Opportunities for dynamic career advancement and development will be available if desired. You'll also enjoy a motivated, friendly and supportive workplace culture.
Phone, laptop, and ongoing training will be provided. This is an opportunity to design your role; in addition to a high level of freedom in how you approach your work, you will also be able to steer the direction of your ongoing training and up-skilling opportunities. Furthermore, while the role will be primarily based in-office at Maryborough, the executive team is open to negotiating a flexible arrangement that, if viable, makes provisions for some off-site/from home hours.
This unique opportunity is located in up-and-coming Maryborough on the Fraser Coast, click here, and here for more information on the area.
Don't miss this exciting opportunity with a cutting-edge organisation - Apply Now!
Please note: Applicants must be an Australian citizen, or have the existing right to work in Australia.