About The Company Join a Global Leader in Clinical Diagnostics Be part of a world-class organisation at the forefront of clinical diagnostics innovation. Through sustained investment in research and development, this company delivers a diverse portfolio of specialty diagnostic solutions trusted by healthcare professionals in over 100 countries. With a global workforce of more than 3,000 employees, the Regulatory Affairs Manager role offers a highly credible opportunity with exceptional scope for impact and professional growth Duties & Responsibilities The main objective for the role would be to maintain and uphold the companies regulatory profile with TGA and other regulatory bodies. You role will be cover responsibilities including; Ensure that all products comply with regulations and laws governing their importation, sale and distribution. Help develop, drive and monitor the company regulatory plans and procedures. Provide strategic and technical advice to the CD/VP APAC. To train and develop company talent in the regulatory area. Manage key relationships with TGA and any relevant audits. The role may evolve with supporting APAC regulatory efforts Main Responsibilities Act as the local expert in RA and as the bridge to Corporate RA functions and stakeholders Collaborate with the commercial team to develop and execute ANZ annual Regulatory Master Plan. Prepare product registration submissions for new products & change notifications to existing products, within agreed timeline in order to ensure regulatory compliance and approval ensuring all products and conformity assessments remain valid or updated accordingly IVDR transition project Understand and advise on relevant company Group Operating Procedures Maintain up‐to‐date knowledge and information on the regulatory environment for medical devices in AU and NZ as relevant for the role. Monitor updates to regulations, guidelines and policies in AU and NZ in relation to the company's product registrations. Key contact and bridge for the organization to TGA, PTA and other key regulatory/industry bodies Support and carry out Field Corrective Actions with Regulatory Authorities Key contact for the local organization to the company in Regulatory & Quality for market vigilance and regulatory compliance activities Provide RA reports to the CD and/or leadership group as required Further Responsibilities Roles reports directly to the Country Direct or If agreed, a support function in APAC may be required or the role may evolve into a full APAC role. Encourage and support internal teams and work collaboratively to contribute to achieving team business outcomes Participate in meetings and represent quality-regulatory perspective to share information and provide input on issue resolution Build and maintain collaborative relationships Address/respond to queries and provide solutions where possible, or redirect query to relevant area About You Education/Specialisation: Bachelor's Degree or higher Experience: 5 years' experience in field of development and implementation of RA processes/ RA management, preferably in IVD or Medical Devices 5 years' experience in driving regulatory process to ensure appropriate and timely filing and approval with TGA Laboratory experience Experience in a similar role, looking for the next step up Technical Competencies: Familiar with relevant regulatory statutes and industry standards, such as ISO 13485, IVDD, GMP, FDA Quality System Regulations, CFR Experienced with the principles and system processes / tools within the RA field Experienced in analysis of RA processes, particularly with respect to compliance, efficiency and effectiveness Demonstrated ability to interpret and apply regulatory and related principles to the workplace Competent with routine application of MS Office, and other common office software, incl. databases Familiarity with the interface of software applications and instruments platform Seasoned experience in using Microsoft Power Point, Word and Excel Benefits Flexible work arrangements Base Salary Yearly Performance Bonus Allowances applicable to Job If you would like to learn more about the opportunity, please contact Kerry McMahon (Managing Director) of KE Select on; 0412 033 014
