Alison Arnot

• Manage and develop the Global Quality Assurance and Regulatory Affairs team to ensure the highest level of service delivery to our internal and external customers. • Develop and advise on Regulatory Strategies for new products and markets. • Ensure that the structure of the Global Quality Assurance and Regulatory Affairs meets the needs of the commercial business. • Responsible for ensuring all products meet all necessary regulatory requirements prior to being released into the markets including approval of packaging and labelling globally. • Develop and maintain good working relationships with key personnel within the designated Notified Body (currently BSi) and equivalent Regulatory Authorities and Notified Bodies globally. • Develop and maintain good working relationships with relevant International and Local Standards organizations. • Ensure all new products and existing product ranges (or newly acquired businesses) comply with regulatory requirements. • Supervise and participate in the compilation of Technical Files and Registration dossiers. • Review all product development documentation to ensure compliance for target markets and compliance to relevant Standards. • Represent global Regulatory Affairs on research and development projects to ensure proposed products and techniques achieve business needs within standards set by the markets and regulatory bodies • Provide technical knowledge and support for market and business development. • Train employees to an appropriate level of efficiency where required in relation to regulatory and quality issues of products and processes. • Ensure all required Quality Management Systems are in place and are appropriately certified to ensure global compliance. • Ensure there is adequate post market surveillance of medical devices globally and that adverse incidents and Safety Alerts are communicated to the appropriate authorities when applicable.

• Manage and develop the EMEA APAC Regulatory team to ensure the highest level of service delivery to our internal and external customers. • Develop and advise on Regulatory Strategies for new products and markets. • Ensure that the structure of the EMEA APAC Regional meets the needs of the commercial business. • Responsible for ensuring all products considered medical devices in EMEA APAC meet all necessary regulatory requirements prior to being released into the markets. • Responsible for ensuring all products considered PPE in EMEA APAC meet all necessary regulatory requirements prior to being released into the markets. • Develop and maintain good working relationships with key personnel within the designated Notified Body (currently BSi) and equivalent Regulatory Authorities and Notified Bodies throughout EMEA APAC. • Develop and maintain good working relationships with relevant International and Local Standards organisations. • Ensure all new products and existing product ranges (or newly acquired businesses) comply with regulatory requirements • Conduct audits of manufacturing facilities as required • Represent the region on research and development projects to ensure proposed products and techniques achieve business needs within standards set by the markets and regulatory bodies • Train employees to an appropriate level of efficiency where required in relation to regulatory and quality issues of products and processes. • Ensure all Regulatory processes are adequately documented in the EMEA APAC Business (Quality) management System and that the System is compliant to the European Medical Device Directive. • Ensure there is adequate post market surveillance of medical devices in EMEA APAC and that adverse incidents and safety Alerts are communicated to the appropriate authorities when applicable. • Actively participate in the EMEA APAC ELT and support the growth and development of the EMEA APAC region.

• Manage and develop the EMEA Regulatory team to ensure the highest level of service delivery to our internal and external customers. • Develop and advise on Regulatory Strategies for new products and markets. • Ensure that the structure of the EMEA Region meets the needs of the commercial business. • Responsible for ensuring all products considered medical devices in EMEA meet all necessary regulatory requirements prior to being released into the markets. • Develop and maintain good working relationships with key personnel within the designated Notified Body (currently BSi) and equivalent Regulatory Authorities and Notified Bodies throughout EMEA. • Develop and maintain good working relationships with relevant International and Local Standards organisations. • Ensure all new products and existing product ranges (or newly acquired businesses) comply with regulatory requirements • Conduct audits of manufacturing facilities as required • Represent the region on research and development projects to ensure proposed products and techniques achieve business needs within standards set by the markets and regulatory bodies • Provide technical knowledge and support for market and business development • Train employees to an appropriate level of efficiency where required in relation to regulatory and quality issues of products and processes. • Ensure all Regulatory processes are adequately documented in the EMEA Business (Quality) management System and that the System is compliant to the European Medical Device Directive. • Ensure there is adequate post market surveillance of medical devices in EMEA APAC and that adverse incidents and safety Alerts are communicated to the appropriate authorities when applicable. • Actively participate in the EMEA ELT and support the growth and development of the EMEA APAC region where and when appropriate.

• Responsible for ensuring all products considered medical devices in Asia Pacific meet all necessary regulatory requirements prior to being released into the markets • Develop and maintain good working relationships with key personnel within the Therapeutic Goods Administration of Australia and equivalent regulatory bodies throughout the Asia Pacific. • Develop and maintain good working relationships with relevant International and Local Standards organisations ie ISO and Standards Australia to ensure they have an understanding of the Ansell business and needs • Ensure product and business process compliance to the relevant standards and criteria of the regional regulatory and government bodies • Ensure all new products and existing product ranges (or newly acquired businesses) comply with regulatory requirements • Coordinate, as required, clinical trials and ensure compliance with all regulations, ensuring that records are maintained at the appropriate standard • Conduct audits of manufacturing facilities as required • Represent the region on research and development projects to ensure proposed products and techniques achieve business needs within standards set by the markets and regulatory bodies • Manage, maintain and adhere to the regional marketing quality systems coordinating all activities such as compliance, complaint handling, corrective actions, product sampling and when necessary, product recalls • Provide technical knowledge and support for market and business development • Schedule and conduct internal audits in accordance with ISO9001 • Manage and coordinate external audits to ensure continually certification to ISO9001 • Train employees to an appropriate level of efficiency where required in relation to regulatory and quality issues of products and processes.

• Responsible for ensuring all products considered medical devices in Australia, New Zealand and Japan meet all necessary regulatory requirements prior to being released into the markets • Develop and maintain good working relationships with key personnel within the Therapeutic Goods Administration of Australia and equivalent regulatory bodies throughout Australia, New Zealand and Japan. • Develop and maintain good working relationships with relevant International and Local Standards organisations ie ISO and Standards Australia to ensure they have an understanding of the Ansell business and needs • Ensure product and business process compliance to the relevant standards and criteria of the regional regulatory and government bodies • Ensure all new products and existing product ranges (or newly acquired businesses) comply with regulatory requirements • Coordinate, as required, clinical trials and ensure compliance with all regulations, ensuring that records are maintained at the appropriate standard • Conduct audits of manufacturing facilities as required • Represent the region on research and development projects to ensure proposed products and techniques achieve business needs within standards set by the markets and regulatory bodies • Manage, maintain and adhere to the regional marketing quality systems coordinating all activities such as compliance, complaint handling, corrective actions, product sampling and when necessary, product recalls • Provide technical knowledge and support for market and business development • Schedule and conduct internal audits in accordance with ISO9001 • Manage and coordinate external audits to ensure continually certification to ISO9001 • Train employees to an appropriate level of efficiency where required in relation to regulatory and quality issues of products and processes.

• Maintenance and development of relationships with key influencers internally and externally across Ansell’s three divisions Occupational, Professional and Consumer • Management of product feedback and enquiry processes • Active support member in crisis management and recovery program team • Media spokesperson for Ansell Personal & Occupational Healthcare PR and Educational issues • Resource for advice to marketing department staff • Special projects assigned by VP Marketing Asia Pacific • Assist the VP Technical Services and Compliance in the implementation, administration and governance of the Trade Practices Compliance program as agreed with the ACCC in December 2003 • Responsible for legal and regulatory compliance in all areas of sales, marketing, supply and logistics for Asia/Pacific • Assists VP TS&C to establish standards and specifications for all company products to comply with Government Regulations • Assist and support marketing and business development efforts within the region • Provide technical support to end-users, distributors, sales and marketing • Schedule and conduct internal audits in accordance with ISO9001

• Establishing, maintaining and developing relationships with key influencers in sexual health and Occupational Health and Safety in Australia & NZ. • Organising and coordinating projects, key events and promotional activity with key influencers • Development and management of educational programmes with a focus on encouraging use of Ansell products • Management of complaint and enquiry processes • Active support member in crisis management and recovery program team • Media spokesperson for Ansell Personal & Occupational Healthcare PR and Educational issues • Resource for advice to marketing department staff • Management of Pharmacy Guild accredited training program for pharmacy assistants • Assist in development and management of sampling programs and activities • Special projects assigned by VP Marketing Asia Pacific.

In 2003 I was a sessional tutor in 2nd year Criminology at the Australian Institute of Public Safety (AIPS). AIPS was a Fully Accredited Higher Education and Training Provider. The Criminology subject was offered as part of the Bachelor of Social Science (Criminal Justice).I was responsible for 73 students and my workload included marking and guest lecturing.

This was possibly the first independent sex industry consultancy service to be established in Victoria and possibly Australia. The business specialised in training and counselling for people employed in all areas of the Victorian sex industry. Other work included lecturing at a range of Victoria’s universities and colleges about sex industry issues as well as providing consulting services to State and Territory governments, media outlets and businesses wishing to access the industry.

In 2002 I worked as a sessional tutor in the Legal Studies department at La Trobe University for the subject ‘Law and Society’ for one semester. I was responsible for 45 students and my workload included marking and guest lecturing.

This position involved the co-ordination of six projects and eight staff who delivered various services to people working within the sex industry in Victoria. This position involved a large amount of report writing, administration, staff supervision and debriefing. In addition to working with paid staff the position required supervision and training of student placements and volunteers. The P.C.V offered a program for sex workers to undertake Community Based Orders which the program manager oversaw. A large component of the position involved liaison and networking with the media, government and non government organizations and the local community around sex work issues.

This was an outreach position to provide HIV and STI education to Victorian sex workers. An holistic approach was taken in the provision of this education. Duties included coordination of workshops, liaison with industry owners, supervision of students and volunteers associates with the project as well as public speaking and media liaison.