Regulatory Affairs Manager

Join to apply for the Regulatory Affairs Manager - Projects role at Device Technologies 2 days ago Be among the first 25 applicants Join to apply for the Regulatory Affairs Manager - Projects role at Device Technologies Since 1992, Device Technologies has been dedicated to improving patients’ lives through leading edge technology and services, supplying hospitals and healthcare professionals with high-calibre medical solutions from around the world. Over 30 years, Device Technologies has developed a reputation for the quality, dedicated service and ongoing support provided by our people. With HQ in Sydney, the company continues to grow, representing over 200 trusted brands, and employing over 1000 highly skilled staff located across Australia, New Zealand and Asia. Geared towards optimal performance, our culture is built on empowering our people to achieve their goals, aligning with wider business objectives. We focus on productivity, continuous improvement, career development and leadership nurturing to foster a superior workforce. The opportunity… This is a new position dedicated to growing regulatory needs of Device Technologies Group companies. In this role you will bring your exceptional regulatory and project management skills together with people leadership, and risk management to ensure subsidiary companies and integration projects meet complex regulatory compliance. Key Responsibilities: Ensure Device Technologies products are in compliance with Australian and New Zealand regulatory requirements Engage with Device Technologies core and subsidiary business stakeholders to ensure regulatory compliance of their activities, perform gap analysis and support their regulatory needs Liaise with subsidiary companies and/or manufacturers to review technical files and ensure complete regulatory compliance in the target region Execute complex regulatory applications, primarily with the TGA for medical devices, to gain local approval within a target timeframe. This may also include combination or IVD medical devices, systems or procedure packs. Assess and advise on regulatory requirements for new product types to Device Technologies or subsidiaries after contractual agreements have been signed Design, lead and participate in improvement or regulatory change initiatives and implementations involving the RAQA Pre-market, Post-market, QA teams and/or wider business/subsidiaries e.g. up-classifications, MDR/UDI/SLK regulatory change implementations, systems development, auditing, or reporting requirements as required to meet the business objectives Develop and maintain internal resources/guidance/training documentation on complex regulatory topics to enable cross-training and streamlining of regulatory processes of Device Technologies and Subsidiaries Develop and maintain excellent working relationships with relevant regulatory bodies and government departments Participate in internal and external audits of Device Technologies and its subsidiaries as required Provide support, training, coaching, mentoring and leadership: to RAQA team members in specialized knowledge areas and with the intention to increase the knowledge and effectiveness of the team; on complex regulatory topics and manufacturing requirements as needed Assist RAQA Leadership through identification of training requirements of the RAQA team Peer-review regulatory applications, audits, files and reports prior to submission to the TGA/Medsafe or other local regulator, as required to ensure accuracy, completeness and successful lodgment Collaborate with RAQA Management team and Business Management to ensure effective and timely regulatory applications in the target region; Approval authority for RAQA departmental functions achieved according to demonstrated competencies; Liaise with both local and overseas suppliers/manufacturers on regulatory issues and to obtain required documentation for regulatory compliance and new applications Maintain accurate and up to date system records, technical files, databases, spreadsheet and registers to demonstrate regulatory compliance Collaborate with and support internal sales and marketing teams with required regulatory information for customer tenders and enquiries Action internal requests for new products, non-conforming quarantined product investigations or release, advertising compliance reviews, etc. Action external requests from the regulator for auditing, reporting or recall purposes, etc. Promote the core values and behavioral code of Device Technologies Assist RAQA Management and RAQA Team with other functions as required About you... At Device Technologies, we succeed through our commitment to five key values: Delivering Innovation - We constantly seek new ideas, technologies, and approaches to meet evolving customer needs and market demands.Through our innovation we continually adapt and transform for our people, our customers and our future success. Seeking Collaboration - By embracing collaboration we tap into diverse perspectives, skills, and resources to drive innovation, solve complex problems, and achieve common goals. Taking Ownership - We embrace accountability and initiative. It fosters trust, collaboration, and empowers our people to drive success through proactive responsibility. Practising Good Business - We strive to embody integrity, responsibility, and sustainability. It involves ethical conduct, transparency, and a commitment to social and environmental stewardship. Championing the Customer - By placing customers at the heart of decision-making and operations, we enhance experiences, foster loyalty, and collectively strive to improve patient outcomes. Our ideal candidate for this role aligns with these values. The ideal candidate will have 8+ years' experience in Australian Therapeutic Goods industry, with proven success in regulatory approvals for complex medical device application and life cycle compliance. You will have a passion for innovation in patient care as well as people leadership, mentoring and development of large cross-functional teams. To succeed in this role you will be a natural communicator and problem solver, driven by deadlines and thriving in a fast paced dynamic environment. Experience required: Tertiary qualification in relevant field (e.g., Medical Science or Engineering, etc.) Minimum 8 years’ experience in a diverse range of products within the Australian Regulatory Affairs environment for Class I-III Medical Devices and other specialty products Knowledge and experience in the application of quality management systems to medical devices manufacture Proven success in regulatory submission for product ranges with complex requirements Formal Project Management experience and training Medical Device manufacturing experience in an ISO 13485 quality management system Internal and external auditing and Quality Assurance experience Experience with SAP, Adobe Professional, SharePoint and Wrike Experience on-boarding and off-boarding, performance discussions and KPI reporting measurement Interested? To apply for this opportunity, please click on the 'apply' button to be redirected to our candidate application portal. At Device Technologies we are motivated by the opportunity our equipment provides to change people’s lives. We have a clear vision to ensure all our people feel valued and respected, can be themselves and can flourish as contributors to the success of our business. Our promise is all qualified applicants will receive consideration for employment without regard to diversity of race, gender, sexual orientation, religion, ethnicity, disability, age and all the other wonderful characteristics that make us different. It is also a mandatory requirement for certain roles within our organisation, where the successful applicant may be required to present certifications and/or vaccinations status as per role requirements. Evidence of certificates or vaccination status will be requested during the interview process by management to qualify fit for role and prior to any offer. Seniority level Mid-Senior level Employment type Full-time Job function Quality Assurance, Research, and Management Industries Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr