Recruiter Summary of Position:

Job Title: Quality Director (Implantable Medical Devices)

Location: Sydney, Australia

Work Arrangement: Remote (12+ month Contract)

Required Skills:

• 7-10+ years of experience working in medical device development and leadership. Implantable medical device experience desired, along with Class II & III regulatory pathways.
• Experience in creating and managing Medical Device Quality Systems.
• Experience taking implantable medical devices to clinical trial and market.
• Experience in carrying out and supporting technical and quality audits.
• Prior experience with ISO 13485, FDA medical device regulations, and TGA required.
• Experience in developing products in compliance to IEC 60601, ISO 14971, and IEC 62304.
• Regulatory submission expertise (FDA 510(k), PMA, TGA).
• Experience leading and scaling teams, ensuring supplier quality, post-market compliance, and audits.

Preferred Skills:

• Experience with EU MDR. Regulatory submission experience with CE Mark.
• Product development experience sought. Operational experience designing new products, overseeing development, and pushing out a Class 2-3 product.

Employer Value Proposition: Lead the quality strategy for a "Breakthrough Designation" neurotech startup. Influence US market entry from the ground up, manage a strategic partnership with a global leader, and report directly to the CEO/CTO.

The Opportunity

As the Quality Director, you will be the strategic architect behind a Quality Management System that supports a life-changing neurotechnology platform. You aren’t just managing a checklist; you are leading a mission to bring breakthrough implantable technology to the global market. You will spend your days bridging the gap between high-level regulatory strategy and hands-on operational excellence, partnering directly with the CEO and CTO to ensure that every innovation meets the highest standards of safety and compliance. This is your chance to scale a world-class quality team, navigate complex FDA and TGA pathways, and leave a permanent mark on the future of neurology.

Why This Role Stands Out

• Lead the Strategy: Drive the long-term QMS roadmap for US market entry and ISO 13485 certification.
• High-Stakes Innovation: Provide quality leadership for Class III active implantable devices with FDA Breakthrough status.
• Strategic Collaboration: Act as the key quality interface between the company and world-class manufacturing partners.
• Build Your Legacy: Scale a quality organization from an early-stage startup into a commercial powerhouse.

What Success Looks Like

Your focus will be on ensuring the company’s QMS is not only compliant but acts as a catalyst for growth. You will oversee quality inputs for critical regulatory dossiers (PMA, 510k), manage global supplier audits, and lead post-market surveillance. By mentoring a growing team and fostering a culture of quality awareness, you will ensure that the transition from clinical trials to commercial success is seamless and robust.

The Profile We’re Looking For

• The Expert: You have at least 10 years of leadership in medical device development, specifically with active implants.
• The Strategist: You have a deep, practical mastery of ISO 13485 and FDA 21 CFR Part 820.
• The Communicator: You can navigate high-level discussions with regulatory agencies one hour and mentor your internal team the next.
• The Visionary: You thrive in the dynamic, "all-hands-on-deck" environment of a growth-stage startup.

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