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Regulatory Affairs

Regulatory Affairs professionals play a crucial role in ensuring that each product is developed, manufactured, and marketed in compliance with regulations, thereby safeguarding overall public health and promoting patient safety.

Welcome to the HPG page dedicated to Regulatory Affairs recruitment. At HPG, we specialise in connecting exceptional professionals with rewarding healthcare jobs, including pivotal roles in regulatory affairs.

Our expert recruitment team focuses on identifying top-tier talent for regulatory affairs jobs, ensuring our clients benefit from professionals who are instrumental in maintaining compliance and upholding the highest standards in healthcare. From regulatory affairs jobs that involve navigating complex legislation to roles that ensure product safety and efficacy, we cover the full spectrum of regulatory support.

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Are you looking for a fulfilling career in regulatory affairs within the healthcare sector? HPG is here to help you find the perfect opportunity. We offer a wide range of regulatory affairs jobs, from entry-level positions to advanced roles that require specialised knowledge and experience. Whether you're interested in working as a regulatory affairs specialist, compliance manager, or regulatory consultant, we have the connections and expertise to match you with employers who value your skills and contributions.

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Jobs in Regulatory Affairs.

Regulatory Affairs

Senior Regulatory Affairs Associate

  • Sydney
  • Attractive Salary Package

Benefits • Work with a global leader in medical technology • Opportunity to contribute to a high-impact product launch • Collaborative environment with flexibility and autonomy   About the Company Our client is a global healthcare leader renowned for developing innovative, life-changing technologies in medical devices. With a strong presence in Australia and across international markets, they are committed to improving patient care and advancing the future of healthcare.   About the Opportunity This is an exciting opportunity to step into a Senior Regulatory Affairs Associate role, supporting a high-priority product portfolio during a critical period of growth. With a significant product launch approaching and regulatory demands increasing, this position is instrumental in ensuring efficient, compliant, and timely pre-market submissions. Reporting to a seasoned Regulatory Affairs Manager, you'll play a vital role in regulatory strategy and operations for the ANZ region.   Duties • Manage end-to-end regulatory submissions, including TGA interactions • Lead regulatory strategy and compile technical files, primarily adapted from EU documentation • Prepare documentation for high-class devices: Class III IVD, Class IIb, and Class III Medical Devices • Review local documentation and assess non-conformance where required • Evaluate the regulatory impact of product and process changes • Review promotional and advertising materials for compliance • Provide regulatory support to cross-functional teams, including commercial and market access   Skills and Experience • Tertiary qualification in a scientific or healthcare-related discipline • Minimum 3 years of Regulatory Affairs experience in medical devices • Strong technical writing experience, especially with regulatory files • Experience working on TGA submissions and promotional material reviews • Intelligent, adaptable, and a strong communicator across functions • Self-motivated, proactive, and capable of managing priorities in a fast-paced setting   Culture You’ll join a lean but dynamic and growing team that values innovation, autonomy, and open communication. This is a culture where big-picture thinkers who also dive deep into detail will thrive. The leadership style is supportive but hands-off, suited to someone emotionally mature and confident in self-managing their workload.   How to Apply Ready to contribute to a high-impact medical device launch? Click apply or contact Gemma Staddon - gstaddon@hpgconnect for a confidential discussion.   About Healthcare Professionals Group Healthcare Professionals Group recruits all positions across healthcare – Pharmaceuticals, Biotechnology, Medical Technology, and Clinical Care. • Medical Affairs & Life Sciences – Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific • Commercial – Marketing, Sales, Analytics, Government & External Affairs • Business Operations & Infrastructure – Administration, Finance, HR, Legal, Supply Chain, IT • Clinical Care – Allied Health, Aged Care, General Practice, Nursing, Medical Imaging

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Quality Assurance,Regulatory Affairs

Quality & Regulatory Affairs Associate

  • Sydney
  • Competitive base salary + bonus

Benefits Ownership of both QA and RA activities with strong mentoring and support Great opportunity for professional growth and cross-functional collaboration Work with a global pharmaceutical company committed to continuous improvement Hybrid working  About the company This global pharmaceutical company offers a broad range of products across international markets. It is known for its focus on quality, compliance, and innovation, with teams working together to maintain high standards in manufacturing and regulatory processes. About the opportunity This is a fantastic opportunity for an experienced Quality professional with some regulatory exposure to step into a broad, hands-on role. You’ll be responsible for managing key quality systems including change controls, deviations, and complaints, while also supporting regulatory activities across a varied product portfolio. Working closely with cross-functional teams and external partners, you’ll play a central role in maintaining compliance and ensuring timely approvals and documentation. The position is well-suited to someone looking to take ownership, make process improvements, and contribute to a high-performing and collaborative team. With hybrid flexibility and strong mentoring, this is a role where you can grow and thrive. Duties Act as the liaison between customers and corporate quality functions Manage change controls, deviations, complaints, and CAPAs Support product quality reviews and GMP compliance activities Prepare and submit regulatory variations and notifications to authorities Provide guidance on labelling and regulatory documentation for submissions Assist with packaging and artwork issue resolution Coordinate cross-functional collaboration with R&D, Supply, and Business Development Identify and support quality system improvements and handle technical queries Skills and Experience Tertiary qualification in Science, Pharmacy, or related discipline 3-4 years of experience in pharmaceutical Quality Assurance or Regulatory Affairs Strong understanding of GMP, TGA, and Medsafe regulatory frameworks Exceptional attention to detail and organisational skills Strong stakeholder communication and project coordination abilities Self-motivated, adaptable, and proactive in driving process improvement Culture Join a collaborative and forward-thinking team that values open communication, innovation, and continuous learning. The company encourages initiative and supports career development through exposure to diverse projects and global best practices. How to Apply Ready to take the next step? Click apply or contact Gemma Staddon on gstaddon@hpgconnect for a confidential discussion. About Healthcare Professionals Group Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare – Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care. Medical Affairs & Life Sciences Recruitment – Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific Commercial Recruitment – Marketing, Sales, Analytics, Government and External Affairs Business Operations & Infrastructure Recruitment – Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse Clinical Care Recruitment – Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing

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