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 areasReview and maintain all medical device and medicine registration requirements to support the ANZ businesses within required timelinesPrepare 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 lifecycleLead the preparation and submission of registration application for medicines with the TGA & Medsafe, including submissions of variations/changes for updates in Safety related, Product and Consumer Medicine InformationMonitor and interpret changes in TGA/Medsafe/WAND regulations to provide strategic advice on submission timelines and impact on existing product portfoliosReview S&M related materials, promotions and for compliance to ANZ advertising regulations and MTAA/MTANZ codesReview device change controls and complete risk assessments based on regulatory impact to ANZ as requestedMaintain a database of all ANZ product certification and manufacturer’s evidence submitted to regulatory authorities to ensure it is contemporaneous and accessible for all FMC teamsAct 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) activitiesServe 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 metMaintain compliance with post market activity such as recall, FSNs/FSCAs and liaising with regulatory authorities, distributors and customers to complete all required regulatory actionsSupport 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 submissionsSupport SE Asian market with documentation requestsSupport HQ/AP regional project teams impacting ANZAd hoc regulatory  and quality related tasks as required to support the ANZ business

Competencies

Knowledge of regulatory requirements for management of medical devices and medicine in Australia and New ZealandExperience in preparing, submitting and handling medical device and medicine applications, change applications, variations and updates to the TGA & WANDUnderstanding of MAH responsibility including Sponsor requirements, device and medicine lifecycle managementUnderstanding of GMP, QSR & ISO 13485 Quality Management SystemsKnowledge of device incident reporting, adverse event reporting; pharmacovigilance experience desirable but not essentialUnderstanding of 3PL supply chain managementStrong organisational and interpersonal skills and able to work autonomously as well as in cross functional teamsStrong problem solving and decision making skillsKnowledge of risk management techniquesComputer 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 desirable but not essentialExperience working in a GMP and/or ISO13485 environmentDirect experience with medical device Conformity Assessment processes; CE marking and MDR experience desirableProven history of successful submissions of device applications (Class I-III) to TGA and WANDProven engagement, both verbal and written, with regulatory authorities and notified bodies such as TGA, Medsafe, US FDA, TUV SUD, BSIProven 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 EnglishStrong verbal and written communication skillsAbility to comprehend and effectively translate complex regulatory information to internal stakeholders and external contactsAbility to collaborate regularly and respectfully with local, regional and cross functional teams to achieve positive business outcomes