Get AI-powered advice on this job and more exclusive features.PolyNovo is an Australian multinational medical device company that designs, develops, and manufactures truly innovative dermal regeneration solutions, including NovoSorb Biodegradable Temporising Matrix (BTM), using our patented NovoSorb resorbable fully biodegradable polymer technology.In the last five years, PolyNovo has grown from 40 staff to more than 265 globally and has now touched the lives of over 50,000 patients. Our lifesaving and life-changing products have revolutionised the treatment of burns and major trauma as well as multiple emerging indications and there is nothing but blue skies ahead with a diverse range of medical device products in the pipeline.With TGA, FDA, CE Mark/ MDR, Health Canada, and other registrations, our world-best polymer devices are enhancing clinical outcomes for patients around the world. See www.polynovo.com for more.About The RolePolyNovo is seeking a Post Market Surveillance Associate to join our growing team. This role will maintain and continually improve the PolyNovo PMS System, which includes administration of documentation, supporting data analysis, and managing the intake and triage of post market information such as complaints, adverse events, serious incidents, and feedback. The duties must be performed in line with jurisdictional regulatory requirements and medical device guidance.Key ResponsibilitiesComplete product complaint and feedback entry including case narrative writing, coding from the MedDRA and IMDRF dictionary as per applicable SOPs and PolyNovo requirements.Perform complaint and other feedback investigations and follow up as appropriate.Review, prepare and/or update relevant PMS procedures and other process documentation.Provide input on PMS trends and investigations, new product projects and continuous improvement projects.Assist in corrective and preventive action initiatives.Assist with all PMS activities according to schedule, gather inputs from cross-functional stakeholders, and escalate at-risk findings.Assist with performing and interpreting PMS data analysis.Ensure compliance to all PMS activities, including alignment to FDA, TGA and EU MDR requirements.Assist coordinating Post-Market Surveillance meetings.Partner closely with Regulatory Affairs, Clinical, Medical and Quality.Interface with sales teams and external reporters to ensure timely intake of information.Ensure compliance with applicable regulations or standard operating procedures.Provide training on SOPs to the newly hired resources.Manage workload under the direction of PMS Lead.Support internal and external audits.Any other responsibilities including cross fulfill business needs.About you:Tertiary qualifications in Health/life Sciences/pharmacy.At least three years experience in post-market surveillance or pharmacovigilance - essential.Previous experience in complaint handling, trend analysis for medical device or medicinal product preferable.Current knowledge of Medical Device Regulation (EU-MDR) and associated vigilance regulations or associated pharmacovigilance experienced preferred.Understanding of quality system regulations (ISO13485; 21CFR820) for medical devices as well as risk management and ISO14971.Excellent communication and interpersonal skills - fluent in written and spoken English.Highly developed technical writing/ editing skills.Ability to acquire, query and analyse data with focus on detail.Ability to work flexibly.Proven ability to take accountability for the quality, accuracy and timeliness of their work outputs.Understand aspects and methods for data analysis, interpretation and presentation desirable.Technical writing skills or previous experience.Understands, interprets, and clearly presents scientific and medical data in verbal and written format (including understanding and application of medical concepts and terminology).Excellent Excel skills and MS Suite.Excellent attention to detail.Why PolyNovoJoin a team that values innovation, collaboration, and professional growth. At PolyNovo, we offer a dynamic work environment and the opportunity to contribute to ground-breaking projects that shape the future of our company and the industry.Work for a global, ASX-listed, values-led business dedicated to improving patient outcomes.Highly innovative products.Dynamic, multicultural, and innovative work environment.Career development opportunities and unlimited access to online learning.Hybrid and flexible working arrangements.Regular rewards and recognition along with access to discounts with over 450 retailers.Salary packaging including novated car leasing.Apply TodayPlease send your resume by clicking on the apply button. Please note that only shortlisted candidates will be contacted.Learn more about PolyNovo at: NOTE ONLY APPLICANTS WITH FULL WORKING RIGHTS IN AUSTRALIA WILL BE CONSIDERED.Seniority levelAssociateEmployment typeFull-timeJob functionManufacturingIndustriesMedical Equipment Manufacturing #J-18808-Ljbffr
Job Title
Post Market Surveillance Associate