Regulatory affairs, quality management. risk management and product evaluation

Medical device quality management and regulatory affairs

o Provides regulatory strategy advice, compiles regulatory documentation and makes submissions to regulatory authorities for approval to supply medical devices, non-prescription medicines, prescription medicines and cellular therapies.o Provides regulatory advice and technical support on scientific, pre-clinical and clinical data requirements for regulatory submissions.o Manages existing product approvals including post-market surveillance.o Designs and establishes ISO 13485 Quality Management Systems.

o Development of ISO 13485-compliant Quality Management System using Greenlight Guru software. Audit support to the Quality Manager, ISO 90001, ISO 13485.o Regulatory support to the existing FDA regulatory submission and primary responsibility for new FDA, TGA and EU regulatory submissions.o Regulatory support to hardware and software engineers and development of software verification and validation documentation.o Development of regulatory labelling including electrical compliance requirements.o Cybersecurity documentation for FDA submission.

Regulatory Leadership and Expertise: Provided expert advice to management and staff on the regulatory requirements for the legal supply of medicinal cannabis products in the Australian market and globally. Assessed regulatory risks and provided risk management advice and strategies. Liaised with vendors, clients and stakeholders to maintain regulatory compliance.Quality Management Support: Provided regulatory advice and document preparation and review support to the Quality team to build and maintain the product quality system (PQS). Managed the documentation and regulatory requirements associated with product deviations, adverse events and mandatory reporting to regulatory authorities. Performed vendor audits in compliance with PQS requirements.Product Manufacturing Support: Provided the Production team with regulatory advice and document preparation and review support to comply with Good Manufacturing Practices (GMP). Supported the regulatory requirements associated with manufacturing deviations, product release and change control.Marketing Claims and Labelling Review: Advised management and Sales and Marketing teams on the regulatory requirements associated with product marketing and advertising claims in print and digital/social media. Proposed solutions according to industry practice and risk level. Reviewed product labelling and product information leaflets for compliance with regulatory requirements in different jurisdictions. Product Stability Studies: Developed stability study protocols, analysed data and wrote stability reports in compliance with regulatory requirements and suitable for inclusion in regulatory submissions.Product Approvals: Developed product dossiers according to applicable local and international standards and guidelines, and managed regulatory submissions and correspondence with regulatory authorities in liaison with global partners.

Regulatory strategy: Developed regulatory strategies for approval of medical devices and cellular therapies for orthopaedics including: o Scientific and regulatory review and analysis of competitor and equivalent products; o Analysis of regulatory requirements and identification and comparison of viable paths to market in Australia, the USA and Europe; o Identification of clinical evidence requirements; and o Gap analyses, identification of evidence deficiencies and product risk analysis.Regulatory submissions: Prepared regulatory documentation for marketing approval of medical devices and cellular therapies according to applicable standards, guidelines and regulations. Engaged with officers at the TGA and FDA, and EU notified body officers in pre-submission meetings and preparation of responses to requests for information, resulting in product approvals.Non-clinical studies: Provided technical and regulatory support for animal study protocol design, animal ethics applications and reporting of animal, in vitro and bench testing studies according to international standards, regulatory guidelines and Good Laboratory Practice (GLP).Biocompatibility: Managed biocompatibility testing and reporting within a risk management framework according to ISO 10993 and ISO 14971.Viral safety: Provided regulatory support and review of viral inactivation studies and reports according to ICH Q5A and ISO 22442-3.Clinical studies: Provided regulatory support to clinical trials in compliance with Good Clinical Practice (GCP). Prepared and reviewed clinical investigation reports and clinical evaluation documentation for regulatory submissions.Quality management: Provided support to ISO 13485 and GMP compliance, change management and quality risk management. Provided support to internal, external and supplier quality audits. Analysed audit non-conformities and prepared and reviewed responses following regulator audits.

o Management of existing product registrations: Managed Pfizer portfolios for oncology products, intravenous solutions and disinfectants, in 24 countries.o Managed compliance requirements with local and international standards (ISO, ASTM), guidelines and pharmacopoeia.o Provided product deviation, change management and supplier management support.

o Provided regulatory support to FDA 510(k) collagen medical device submission resulting in device approval.o Prepared GLP-compliant non-clinical study reports.o Provided technical and regulatory support to technical transfer and scale-up of pilot medical device manufacturing to a large scale state-of-the-art clean room facility.o Developed technical training materials and documentation and conducted training for collagen medical device manufacturing.o Supported establishment and implementation of the ISO 13485 quality management system.

o Conducted scientific evaluation of product dossiers and regulatory reviews of applications for approval of medical devices, prescription medicines and cellular therapy products.o Managed regulatory submissions including liaison with virology, microbiology, chemistry, toxicology, clinical, manufacturing and legal departments at the TGA.o Handled freedom of information (FOI) requests and ministerial briefings