Position: Senior Regulatory Affairs Specialist
Sector: Biotechnology & Genetics (Science & Technology)
Employment Type: Full time
The Senior Regulatory Affairs Specialist is a key part in managing the regulatory aspects of the IVD devices, including assays and instruments.
The Senior RA Specialist will be responsible for overseeing new product development, on-market regulatory activities, and national and international regulatory submissions associated with various regulatory agencies, including EU Notified Bodies.
The Senior Regulatory Affairs Specialist will independently support cross-functional teams in new product development by providing regulatory advice and preparing regulatory content for both national and international submissions.
Key Duties:
Independently support new product development or product changes including regulatory assessment and preparation of regulatory content for national and international submissions for IVD medical devices.
Ability to interface with cross-functional teams and regulatory agencies.
Prepare, compile and submit pre-market and post-market regulatory documentation with TGA, MHRA (UK) and EU.
Compile IVDR compliant Technical Documentation for IVD medical devices to support EU CE-Mark.
Review product labeling, materials for publication, literature and website for accuracy, consistency and regulatory compliance.
Develop, review and/or approve regulatory procedures.
Review new product design protocols related to verification and validation, risk assessment, etc.
Mentor and instruct junior staff members on how to complete key regulatory activities such as submissions.
Supervise and take responsibility for the quality of work completed by junior staff on shared projects.
Support on-market regulatory activities as assigned by management.
Assess and communicate new and/or updated regulations to technical functions within AusDx.
Perform regulatory assessment on reporting requirements for complaints or adverse trends as well as notification requirements for substantial change within AusDx.
Prepare and facilitate third-party audits as necessary.
Required Qualifications:
Bachelor's Degree in life sciences or biomedical engineering with a minimum of 5 years direct experience in Regulatory Affairs within the IVD or medical device industries.
Required Skills and Experience:
Strong experience with IVD and software/instrumentation is preferred.
Solid working knowledge of the TGA Regulations, UK MHRA and European IVD regulations and directives.
Good analytical and problem-solving skills.
Good understanding of technical/scientific principles related to IVD reagent chemistry, and instruments IVD.
Experience working on multiplexed test panels highly desired.
At AusDiagnostics we try to go above and beyond for our people offering a supportive and vibrant workplace where you can truly make a difference.
Join our team and collaborate with industry leaders, contribute to meaningful advancements, and enhance your personal and professional growth.
We are a values-driven organization committed to cultivating a supportive and collegial team culture.
Benefit from the opportunity to work autonomously, empowering you to take charge of your own success.
Our head office is conveniently located near public transportation, cafes, and restaurants.
We have free parking available on site.
We provide comprehensive health insurance for all employees.
All employees are entitled to a day off to celebrate their birthday.
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