Associate Director, Regulatory Affairs and Quality Assurance

Job Description

Associate Director, Regulatory Affairs and Quality Assurance Posted: 25/02/2025 Closing Date: 28/03/2025 Job Type: Permanent - Full Time Job Category: Executive Medline - Together, advancing healthcare Medline is a healthcare company - a manufacturer, distributor and so much more, doing business in more than 125 countries and territories around the world. We provide the quality medical products and solutions our customers need to deliver their best care to every person in every care setting. Medline is committed to reducing our carbon footprint, developing responsible products, supporting our employees and local communities, and promoting high ethical standards internally and among our supplier partners. Click here to discover what Medline is doing to make healthcare more sustainable for people and the planet. Job Description Medline is seeking an experienced and dynamic Executive Leader to join our team as the Associate Director, Regulatory Affairs and Quality Assurance. Reporting to the General Manager Operations, this role will focus on effective leadership, strategic development and business partnering to manage risk and outcomes for Medline aligned to the business strategy. Your primary tasks will include: Responsible for developing and shaping Medline’s RA/QA strategy, ensuring alignment with the organisation's goals. Provide strategic leadership, make critical decisions, and allocate resources to execute and drive the successful implementation of the strategy while monitoring its progress and adapting as needed Use your expertise to manage areas of regulatory ambiguity that provide the most favorable outcome for the organization, whilst taking into account risk/reward situations Develop relationships with International QAand RAteams and key influencers to champion ANZ needs, especially International Legal Manufacturers to support ANZ products Transform broad ideas into thoughtful solutions that can be implemented to deal with challenges and business partner closely to help lead and implement this change within the business Drive the Quality Assurance program to maintain the Conformity Assessment Certificate to manufacture according to ISO13485 as well as adherence toISO9001,ISO14001, ISO 11135 and the Australian Medical Device Regulations Leading regulatory agency interactions and communications on behalf of Medline ANZ Responsibility for any Substantial Change applications and remediations for existing products Keeping abreast of changes in regulations and standards that may impact the business and prioritizing this learning amongst the teams. Mentoring and developing a high-performing team of regulatory affairs and quality professionals. Provide guidance, feedback, role clarity and opportunities for growth. Desired Skills and Experience A career with a difference We want to hear from candidates who possess strong leadership skills, have extensive knowledge of regulatory requirements within the medical devices field and a proven track record of commercial business partnering. If you are a strategic thinker with a passion for driving excellence in regulatory affairs and quality assurance, we encourage you to apply for this pivotal role at Medline. It takes every team member for us to succeed. At Medline you can expect to feel respected, enjoy your work, reach your potential, and be given the opportunity to do more - and go further. We are proud to be an equal opportunity employer and welcome your unique contribution regardless of your culture, ethnicity, life stage, race, gender identity, disability, or religious beliefs. #J-18808-Ljbffr