Regulatory Affairs Specialist

Scope of Role:

The role is based in Sydney and may require some local and interstate travel. The role encompasses a range of pre and post market product activities and requires:

• interaction and negotiation with regulatory agencies in Australia and New Zealand;
• collaboration across local regional and cross functional regulatory quality clinical and pharmacovigilance teams to support the ANZ business and maintain regulatory compliance;
• working closely with key internal stakeholders namely S&M Finance Legal Clinical Supply chain and Technical teams to ensure no interruption to product supply within ANZ and to drive commercial initiatives and new products to market to grow the ANZ business.

The role supports 3 key business areas within ANZ FMC Devices/Medicines (including Smithfield manufacturing) Packs Seating.

Responsibilities

• Maintain regulatory compliance across all ANZ device and medicine related pre- and post- marketing activities for the 3 key business areas
• Review and maintain all medical deviceand medicineregistration requirements to support the ANZ businesses within required timelines
• Prepare and submit medical device applications to TGA and notifications to WAND including managing post-market variations and change notifications to ensure continuous compliance throughout the product lifecycle
• Lead the preparation and submission ofregistration application formedicines with the TGA & Medsafe including submissions of variations/changes for updates in Safety related Product and Consumer Medicine Information
• Monitor and interpret changes in TGA/Medsafe/WAND regulations to provide strategic advice on submission timelines and impact on existing product portfolios
• Review S&M related materials promotions and for compliance to ANZ advertising regulations and MTAA/MTANZ codes
• Review device change controls and complete risk assessments based on regulatory impact to ANZ as requested
• Maintain a database of all ANZ product certification and manufacturers evidence submitted to regulatory authorities to ensure it is contemporaneous and accessible for all FMC teams
• Act as the Primary LSO for ANZ: Responsible for the assessment and determination of safety events. Manage direct communications with the TGA and serve as the main regulatory contact point for all device-related incident reporting and Post-Market Surveillance (PMS) activities
• Serve as Deputy CCA and Deputy PVRP: Provide essential support for complaint management and medicine safety. This includes the timely and accurate data entry of complaints into the global quality system and assisting the Primary PVRP to ensure all regulatory timelines are met
• Maintain compliance with post market activity such as recall FSNs/FSCAs and liaising with regulatory authorities distributors and customers to complete all required regulatory actions
• Support the maintenance and update of Local Quality Management System (QMS) documentation and SOPs to ensure alignment with FMC global policies and local ANZ standards

Other responsibilities

• Support the S&M team with documentation required for tender submissions
• Support SE Asian market with documentation requests
• Support HQ/AP regional project teams impacting ANZ
• Ad hoc regulatory and qualityrelated tasks as required to support the ANZ business

Competencies

• Knowledge of regulatory requirements for management of medical devices and medicine in Australia and New Zealand
• Experience in preparing submitting and handling medical deviceand medicineapplications change applications variations and updates to the TGA & WAND
• Understanding of MAH responsibility including Sponsor requirementsdeviceand medicinelifecycle management
• Understanding of GMP QSR & ISO 13485 Quality Management Systems
• Knowledge of device incident reporting adverse event reporting; pharmacovigilance experience desirable but not essential
• Understanding of 3PL supply chain management
• Strong organisational and interpersonal skills and able to work autonomously as well as in cross functional teams
• Strong problem solving and decision making skills
• Knowledge of risk management techniques
• Computer literacy with Microsoft Office/Office 365 sharepoint and knowledge of ERP systems databases such as Trackwise QDoc and Doc control platforms

Experience

• At least 3 years previous regulatory affairs experience in the medical device or life sciences industry;pharmaceutical experience is desirablebut not essential
• Experience working in a GMP and/or ISO13485 environment
• Direct experience with medical device Conformity Assessment processes; CE marking and MDR experience desirable
• Proven history of successful submissions of device applications (Class I-III) to TGA and WAND
• Proven engagement both verbal and written with regulatory authorities and notified bodies such as TGA Medsafe US FDA TUV SUD BSI
• Proven QMS experience relating to medical devices including complaint handling reporting to regulatory authorities (incidents events) recalls FSNs/FSCAs

Education

• Degree qualified in a science engineering or healthcare discipline

Communication Effectiveness

• Fluency in English
• Strong verbal and written communication skills
• Ability to comprehend and effectively translate complex regulatory information to internal stakeholders and external contacts
• Ability to collaborate regularly and respectfully with local regional and cross functional teams to achieve positive business outcomes