• Diverse Document Control / Regulatory Affairs role in an innovative business
• Entrepreneurial working environment with plenty of development opportunities
We are a boutique medical device company that develops, supplies and markets high quality, innovative surgical devices – from niche products to proprietary surgical instruments – for minimally invasive and open surgery.
We currently have an opportunity for an experienced Document Control / Regulatory Affairs Associate to drive processes to obtain regulatory approvals in relevant markets to ensure the company’s products meet regulatory requirements and approved to be sold globally. As well as offering administration assistance in document control for the company Quality Management System (QMS).
Based in Carrum Downs, the role will work closely with international manufacturers, international customer, regulatory bodies and quality management team to make sure that all documents is up to date in line with ISO13485 and regulatory standards.
If you are a passionate about processes, detail, providing exceptional documentation, team work and have great organisation skills then this role is for you!
Roles and Responsibilities
• Work with the team to manage and drive processes to obtain regulatory approvals in relevant markets to ensure ORC’s products meet regulatory requirements and approved to be sold in different markets.
• Develop and maintain high level relationships with international partners on regulatory matters.
• Assist to ensure products are launched in a timely and professional manner.
• Maintain and ensure continued compliance of the QMS in line with ISO 13485, FDA 21CFR820, EU MDD, EU MDR, MDSAP and other regulatory requirements in relevant market.
• Ensure international regulatory requirements are addressed and met. All regulatory projects are planned and documented within the Quality Management System.
• These including product registrations, complaints handling, medical device reporting and product recalls handling.
• To review and implement new relevant requirements for medical devices and our contract manufacturers. Proactively identify compliance gaps and corrective actions that are required to maintain ISO accreditation by TGA and other regulatory bodies, such as US FDA.
• Liaise and develop relationships with all relevant accreditation bodies to establish audits and understand the trends or changes in regulations that will impact company business.
• Ensure all RA payments to government or regulatory bodies are made by the required dates in conjunction with the Finance Manager.
• Managing with a sense of urgency the internal and external processes associated with submitting regulatory applications to the appropriate authorities, and maintaining regulatory approvals. This includes working internally and on clinical trials and liaising with external contact manufacturers to obtain the appropriate registration in areas of contracts partner/potential partners.
• Managing and maintain all regulatory registrations in accordance with the latest standards (e.g. FDA Registrations).
• Assist in the process of reporting and preparing submissions to a high standard for Adverse Events Reporting.
• Assist in customer complaints processes.
• Update and maintain regulatory documentation pertaining to QMS of the company based on ISO 13485 and relevant regulatory standards / legislations.
• Complete Product Release Checklists and crosscheck before sign off on manufactured product.
• Provide administration and documentation support to Quality Assurance & Regulatory Affairs Manager and Quality Assurance & Regulatory Affairs Associate
• Assist Quality Manager with filing of QMS documents both hard and soft copy accurately and timely.
• Assist with audits when needed for retrieving files.
• Attend to ad hoc tasks when required.
Key Work/Behavioural Competencies
• Demonstrated flexibility, including an ability to respond quickly and decisively to the changing requirements.
• Adaptability, including the ability to learn quickly and proactively initiate action in a dynamic environment.
• Problem solving, ensuring that all key stakeholders are part of the solution.
• Strategic and analytical thinker, with a can do, must do attitude.
• Strong customer focus.
Education and Experience
• Proven organisational, prioritisation and planning skills.
• Strong administration skills – organised, attention to detail and ability to multi-task
• Ability to work under pressure and to meet deadlines.
• Ability to manage all aspects of the Regulatory Affairs as required by Regulatory / Notified Bodies based on relevant regulatory standards and legislation
• Ability to use initiative and learn a new industry.
• Understand the importance of urgency on customer complaints, adverse event reporting and product recalls.
• Intermediate to advanced skills using Microsoft Office including Microsoft Outlook, Word, Excel, PowerPoint and Adobe, some CRM experience.
• Minimum of 2-3 years’ experience in a similar role.