- Lead quality & regulatory functions for a medical device manufacturer
- Influence key decisions reporting directly to C-suite
- Melbourne Based. Up to $230k base + super + Bonus
Key Responsibilities
- Provide strategic and operational leadership for all Quality and Regulatory Affairs teams, ensuring the management of all departmental activities aligns with company goals and policies.
- Oversee the company’s Quality Management System ensuring local and international compliance with standards such as ISO13485, MDSAP, GMP, and Medical Device Regulation (MDR).
- Act as Management Representative for key global regulatory bodies
- Lead and manage product registration and compliance processes across global markets; oversee timely maintenance and renewal of product registrations.
- Ensure quality processes and QMS documentation meet compliance requirements and that all staff are aware of regulatory standards across the business.
- Monitor and maintain ongoing compliance with evolving regulatory requirements, liaising regularly with overseas offices, distributors, and external consultants.
- Prepare regular Regulatory Affairs reports covering product registration and renewals, and monitor SDI’s IP and trademarks for product protection.
- Foster strong working relationships across internal teams (QC, R&D, Sales & Marketing, Production) and with external stakeholders, including regulatory bodies and consultants.
- Willingness and ability to undertake local, interstate, and international travel for trade shows or site visits (1–2 weeks as required)—is essential.
- Tertiary qualification (Bachelor or Masters) in Sciences or Chemical Engineering highly regarded
- Minimum 5 years’ experience in the medical device industry, specifically within QA and/or Regulatory Affairs management.
- Deep knowledge of international medical device regulatory frameworks, with strong MDR experience and proven expertise in ISO13485, MDSAP, FDA, TGA, MHRA, GMP, or equivalent standards.
- Excellent understanding of manufacturing workflows, culture, and compliance standards.
- Outstanding leadership, communication, and project management skills, with a hands-on, adaptable approach.
- Demonstrated ability to manage relationships at all levels, both internally and externally, and build cohesive, high-performing teams.
- Analytical, strategic thinker with strong problem-solving capabilities and resourcefulness in addressing regulatory challenges.
- Highly organised, detail-oriented, and able to prioritise in a dynamic environment.
- Highly competitive salary package: $200,000 – $230,000 base plus super
- Generous incentive structure, including yearly Short-Term Incentives (STI) paid twice annually (5% each half year) and Long-Term Incentives (LTI) with substantial rewards after three years of service
- Opportunities to shape business strategy, with quarterly leadership meetings and direct influence on key decisions
- Engaging team culture, including quarterly business-wide get-togethers with company-wide presentations
- Regular recognition of excellence through prestigious industry awards
- A values-driven, collaborative environment that values innovation, professional growth, and international exposure
If you are an experienced quality and regulatory leader looking to make a significant impact in the medical device space, we invite you to apply.
Please submit your CV and a cover letter outlining your relevant experience and motivation for this role or apply via Seek below
For a confidential chat, contact Karen Thorne at Ink Recruitment on +61 (0)420 788873
#SCR-karen-thorne
