Head Of Regulatory Affairs

• May 2022 - Present

Regulatory Affairs Manager, CDx

• Jun 2021 - Apr 2022

Global Regulatory Affairs Manager

• Jan 2019 - Aug 2020

Managed all regulatory functions relating to Saluda’s products and developed the company’s regulatory processes and capabilities. Directed interactions with regulatory authorities to obtain approvals and resolve issues. Developed and executed regulatory strategies and plans, providing guidance on regulatory requirements and approaches to manage regulatory risk.Key Achievements & Contributions:• Secured Saluda’s first regulatory approval (CE marking of AIMD system), allowing the company to commercialise and commence sales in Europe • Recruited, managed, and developed the Regulatory Affairs team with 0 turnover in 3 years• Transformed key relationship with EU Notified Body, building confidence in Saluda as a medical device manufacturer• Promoted to Global Regulatory Affairs Manager for exceeding goals and improving regulatory compliance of the company • Conducted regulatory review meetings with senior executive team, presenting strategies, options, and recommendations for regulatory submissions (EU AIMDD, EU MDR, PMA supplements, IDE supplements) and commercial activities • Successfully oversaw market access activities for Australia, including TGA regulatory approval, PLAC reimbursement listing and ACMA radio compliance with all activities completed in timeframes communicated to the business• Performed significant remediation of technical documentation, comprising gap analysis of existing testing, reverification activities, overhaul of product labelling, and update of design dossier• Delivered regular company-wide regulatory training (50+ participants) • Undertook review of clinical documentation including study and safety protocols and reports and supported CER development • Oversaw Saluda’s electronic IFU (eIFU) compliance in line with European Regulation 207/2012 and radio compliance to the requirements of EU Radio Equipment Directive 2014/53/EU Show less

Regulatory Affairs Manager

• Aug 2017 - Jan 2019

Principal Regulatory Affairs Specialist

• Dec 2016 - Aug 2017

Responsible for managing and supporting product registrations and renewals with regulatory authorities across the Asia Pacific region, including Australia, Korea, India and South East Asia. Optimised regulatory processes to reduce variation and to standardise and improve time to market for Cochlear products. Reviewed design, labelling and manufacturing changes and provided input on regulatory impact for Asia Pacific product registrations. Reviewed and approved marketing material in compliance with local advertising and promotion regulations.Key Achievements & Contributions:• Secured over 100 product licence registrations and renewals across Asia Pacific. All (100%) submitted products received regulatory approval within the timeframes communicated to the business• Oversaw one direct report to support regulatory activities in China, Hong Kong and Taiwan. • Managed the regulatory strategy for a new device and accessories during a 50% secondment to the corporate RA team, whilst continuing with Asia Pacific responsibilities. Compiled and submitted regulatory dossiers to EU Notified Body and US FDA with minimal queries and approval granted within timeframe defined in strategy• Developed, communicated, and implemented the quality and regulatory strategy to comply with newly introduced regulations in Malaysia, ensuring business continuity for 100% of products before enforced deadline and passing all external quality audits with no findings• Conducted in-person negotiations and discussions with regulatory authorities regarding product registration strategies and legislation changes, including Singapore HSA, Malaysia MDA, and Australia TGA• Implemented and chaired monthly meetings between APAC Regulatory team and Swedish (manufacturer) Regulatory group to exchange updates on products and approvals, and to align on strategies and timelines• Organised training and introductions for new regional regulatory colleagues Show less

Senior Regulatory Affairs Specialist

• Jun 2014 - Dec 2016

Regulatory Affairs Specialist

• Feb 2013 - May 2014

Regulatory Affairs Officer

• May 2011 - Nov 2012

Regulatory owner of legal manufacturer activities for a well-established global brand of in vitro diagnostics and medical devices for professional use, comprising Women’s Health, Infectious Disease, Respiratory and Oncology products. Management of intra- and inter-company relationships with multiple manufacturing sites and stakeholders globally. Key Achievements & Contributions: • Compilation and submission of regulatory documentation for global registrations, including Design Dossiers for Conformity Assessment under the new Australian TGA IVD regulations, and Common Submission Dossier Template documents (CSDT) for the Singapore HSA. • Regulatory lead for European Notified Body audits for Annex II List B IVD and Class I(s) medical devices, achieving successful outcomes with no regulatory findings. • Accomplished successful rebranding of core products within the Women’s Health business unit, comprising changes in product and legal manufacturer name, redesign of product labelling, update and creation of product technical documentation, and preparation and communication of regulatory timelines to relevant stakeholders. • Key participant in combined ISO 13485 surveillance and Notified Body transfer audit to facilitate a voluntary change in Notified Body. Successfully planned and executed the market transition to updated products with no disruption to product supply through negotiation of timeframes with previous and new Notified Bodies. • Launch of a Class I(s) medical device in compliance with European Directive 93/42/EEC, involving creation of multi-lingual artwork, compilation of technical documentation, CE marking and notification to European Authorised Representative. • Undertook medical device reporting to European Competent Authorities and Regulatory Bodies in line with MEDDEV 2.12-1, including the compilation and presentation of Periodic Summary Reports of adverse events to the UK MHRA on a quarterly basis. Show less

Regulatory Affairs Officer

• Jun 2010 - Apr 2011

Responsible for managing product registrations with global regulatory authorities for an extensive portfolio of transfusion medicine diagnostic medical devices. Liaised with regulatory bodies and external customers/distributors to provide information to support regulatory processes. Key Achievements & Contributions: • Supported the product launch of a quality control system of simulated whole blood reagents in over 40 countries within Europe, Latin America and the Asia Pacific region, on behalf of Ortho Clinical Diagnostics (previously a Johnson & Johnson company). • Established and maintained Product Technical Files to ensure compliance with both EU and US regulations, including compilation of Device Master Records. • Prepared and submitted Prior Approval Supplements (PAS) and Changes Being Effected (CBE) supplements for an existing monoclonal antibody Biologics Licence Application (BLA) to the US FDA. All changes successfully reviewed and approved by FDA. • Actively participated in US FDA Pre-Approval Inspection (PAI), providing auditors with an overview of the regulatory documentation. • Created, reviewed, and updated product labelling & Instructions for Use to improve regulatory compliance with European and US requirements. • Successfully coordinated and executed bi-annual US shipping validation for blood grouping reagents and control products to establish documented evidence that an adequate state of control and product stability are maintained. • Developed the regulatory strategic plan for the product launch of a range of rare antisera in Europe, Latin America and the Asia Pacific region, outlining submission requirements and target timeframes for completion. Show less

Regulatory Affairs Specialist

• Oct 2009 - Jun 2010

Preparation and maintenance of regulatory documentation and materials in compliance with ISO 13485 and the IVD Directive 98/79/EC. Supported the transfer of products and regulatory knowledge to affiliate companies and aid in manufacturing site closure. Key Achievements & Contributions: • Redesigned the mechanism for trending customer complaints for post-marketing surveillance purposes, improving the effectiveness of complaint resolution and identifying significant changes in trends. Delivered training in the use of and regulatory requirement for this process to global affiliate companies. • Successful registration of products globally, including EU notifications in line with European Directives 98/79/EC and 93/42/EEC, and compilation of a product dossier for the Chinese SFDA. • Maintained product-specific Technical Files to comply with regulatory quality systems and in accordance with European Directives 98/79/EC and 93/42/EEC. • Served as company contact for regulatory enquiries from global affiliates and third party distributors. Regulatory point of contact for the transfer of a professional branded IVD device to affiliate companies in Israel and Australia. • Reviewed potentially reportable incidents and prepared medical device/vigilance reports for submission to EU Competent Authorities. • Maintained a product registration database and SAP regulatory control mechanism that resulted in compliant shipments meeting specific country regulations. Show less

Quality Control Technician

• Oct 2006 - Oct 2009