Our client is an innovative, market-leading product manufacturer with operations spanning multiple international markets. Operating from a state-of-the-art manufacturing and R&D campus, they design, develop and manufacture their products in-house, offering a collaborative environment where engineering, quality, commercial and manufacturing teams work closely together to bring innovative products to customers worldwide.
This is an exciting opportunity for a Regulatory Specialist / Senior Regulatory Specialist to take ownership of global product compliance across an extensive product portfolio. You'll play a key role in ensuring products achieve and maintain regulatory approvals across international markets while working closely with certification bodies, test laboratories and cross-functional teams from concept through to product launch and beyond.
Key Responsibilities
- Develop and manage global product compliance strategies.
- Lead product approvals, certifications and technical documentation.
- Coordinate testing with external laboratories and certification bodies.
- Act as the primary contact for Notified Bodies and regulatory authorities.
- Support ISO 9001 Quality Management System activities and post-market compliance.
- Partner with Engineering, R&D, Quality and Commercial teams throughout the product lifecycle.
About You
- Degree in Engineering, Science or a related discipline.
- 4+ years' experience in Product Regulatory Affairs, Product Compliance or Product Certification within manufacturing.
- Strong knowledge of global regulatory frameworks and international product approvals.
- Excellent project management, communication and stakeholder management skills.
Desirable:
- Master's degree or regulatory qualification.
- Experience working with companies that design and manufacture their own products.
- Experience supporting global market access.
- An understanding of electronics regulatory standards
If you would like to find out more about this role please click the 'Apply Now' button below or reach out to Kellie on 021 2300 300
