Join us today and make a difference in people's lives! Position title: Regulatory Affairs Specialist – LivaNova Australia Reports to: Quality Engineering & Regulatory Affairs Manager – LivaNova Australia Function: Regulatory Affairs, Commercial Quality Location: Australia (Melbourne) Position Summary: We are seeking an experienced Regulatory Affairs Specialist to manage regulatory activities for Australia and New Zealand. This role will serve as a regulatory liaison with internal cross functions as well as the regulatory authorities in Australia and New Zealand to ensure ongoing compliance throughout the product lifecycle. The candidate is expected to partner cross-functionally with Supply Chain, Commercial, Legal, and Global Quality functions to support product availability, customer satisfaction, and regulatory compliance. General Responsibilities: Prepare, submit and manage regulatory applications to TGA, including new registrations, variations and any other related regulatory applications Maintain and update regulatory approvals and licenses in accordance with local regulatory changes Monitor, interpret and share with internal relevant stakeholders new or revised TGA / MedSafe regulations and guidance's to assess the impact on company products and processes Act as the regulatory point of contact with local regulatory authorities during audits, inspections and queries Provide strategic regulatory input during product development and localization phases Secure relevant licenses (e.g., environmental, telecommunications & etc) for import and sale of the devices imported by LivaNova Australia in accordance with local regulations and guidelines by other government agencies Perform and manage the RA impact assessment for the product registered in Australia and New Zealand. Support and act as a liaison between the LivaNova BU’s and the New Zealand (NZ) sponsor to register product with the Medsafe and perform any RA impact assessment for changes for products registered in the NZ Support the QE/RA Manager in the maintenance of the Quality Management System (QMS) of LivaNova Australia Skills and Experience: Minimum 3 years of experience in regulatory affairs and quality in medical device companies Strong knowledge of TGA’s regulations Knowledge of ISO 13485 & ISO 14971 preferred Proven experience with TGA submissions and direct communication with regulatory authorities Highly organized, detail-oriented, analytical, able to multi-task, effective team player Education: Bachelor’s degree or higher in life sciences, pharmacy, medical technology, biomedical engineering or a related discipline Travel Requirements: N/A Valuing different backgrounds: LivaNova values equality and diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination. Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification. Notice to third party agencies: Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for “See Open Jobs” on https://www.livanova.com/en-us/careers , and check that all recruitment emails come from an @livanova.com email address.
