Regulatory Compliance Specialist

Prepare & maintain regulatory docs, coordinate with teams & regulators, and ensure products meet all global requirements.Support regulatory activities for innovative orthopaedic products across global markets.Apply your regulatory expertise while collaborating closely with cross-functional teams.Join a passionate team where collaboration, integrity, and excellence drive everything we do.About us: Enztec, are not just shaping the future of orthopaedic instruments and implants; they're pioneering innovation with precision and passion. As a leading orthopaedic and medical device manufacturer, Enztec’s commitment to excellence drives every aspect of their work. From their cutting-edge design processes to their unwavering dedication to customer satisfaction, they're revolutionising the orthopaedic industry one instrument at a time. With a passionate team of experts and a culture of collaboration, Enztec is where innovation meets craftsmanship, and where every individual contributes to their collective success.About the role:Reporting to the Regulatory Affairs Manager, this specialist position plays a critical role in ensuring Enztec’s products meet the regulatory requirements of global markets. You’ll work confidently across regulatory frameworks (including EU MDR, FDA, TGA, Medsafe), preparing and maintaining documentation for new and bespoke medical devices, and championing the importance of regulatory affairs by advising design, engineering, and sales teams on relevant regulatory considerations.In addition to building strong internal relationships, you’ll collaborate with regulatory bodies, clinical advisors, and key external stakeholders, contributing your expertise across the product lifecycle while helping maintain Enztec’s high standards of compliance and quality. This role is ideal for someone who thrives in a collaborative environment and enjoys applying specialist knowledge to complex, meaningful work. With a strong cross-functional approach and genuine engagement across the wider business and the incredible customers Enztec partners with, key accountabilities for this role include:Create, maintain and review technical documentation, submissions, and filings for global markets, including interaction with Regulatory Bodies and customer stakeholders to ensure all regulatory requirements are met.Provide specialist regulatory advice to Design, Engineering, and Sales teams, supporting cross-functional alignment and contributing to solutions that balance compliance with user-focused design.Contribute to the preparation and authoring of Clinical Evaluation Reports (CERs) in accordance with EU MDR and international regulatory requirements.Contribute to post-market surveillance activities and compliance across all phases of the product lifecycle.Participate in customer and regulatory audits, supporting the Quality Team with regulatory documentation and subject-matter insight.Work within Enztec’s QMS procedures related to design controls and technical documentation, supporting continuous improvement of regulatory capability across the organisation.Stay informed on evolving regulations and contribute to embedding best practice across Enztec’s systems and processes.About You: As a regulatory professional with a passion for innovation and teamwork, you enjoy translating complex regulatory requirements into practical solutions. You thrive when working cross-functionally to bring compliant, high-quality products to market and are naturally curious in staying up to date on global regulatory standards - bringing a thoughtful approach to applying best practice across your work.You’re comfortable navigating complexity, assessing risk, and contributing to continuous improvement with accuracy, empathy, and sound judgement. You pride yourself on being able to enhance internal networks and communication processes through utilising your transparent, direct and natural communication style that builds trusted relationships with all those you work with. You take pride in supporting strong internal networks and contributing to smooth, transparent processes that enable teams to do their best work.Enztec embodies a culture driven by passion, innovation and a positive, proactive approach to pushing boundaries. This ethos has solidified Enztec’s reputation as the gold standard in the global orthopaedic manufacturing and supply industry, and we’re seeking a Regulatory Compliance Specialist who brings a commitment to excellence and actively supports regulatory compliance, innovation, and collaboration. We are looking for:A tertiary qualification in a science, engineering, medical, or related disciplineProven experience in the medical device sector, including a sound understanding of the product development lifecycle, medical device design controls, and risk analysisExperience working in an ISO13485 regulated environment, and knowledgeable in the EU, US, Australia and NZ regulatory processes for medical devicesExceptional communication skills with the ability to explain regulatory concepts and impacts clearly to a range of stakeholdersA clear writing style with experience in documenting technical processes and authoring high quality reportsExcellent attention to detail and organisational skillsProcess-driven future-focused mindset focused on optimising documentation and streamlining system efficienciesCommitment to promotion of and upholding a safe, inclusive and medically sanitary work environment that upholds compliant ethical standards.Ready to Apply? Starting a new role in 2026 is the perfect moment to step into fresh challenges, new energy, and meaningful work. If you’re ready to contribute your regulatory expertise to next generation orthopaedic instruments and medical devices - while ensuring strict compliance and enjoying the process, apply today.We have partnered with Bespoke Approach to recruit this role so apply with your Cover Letter and CV via LinkedIn or send your application directly to nikkie.white@bespoke-approach. Applications close Wednesday, 3rd of December at 5:00pm.