Senior Quality & Regulatory Affairs Specialist

NES Fircroft; Sydney; Hybrid; AUD 140,000 - 190,000; Full time

Benefits offered by this job

Hybrid working arrangements

Job summary

NES Fircroft is assisting an innovative Australian medical device company in Sydney to recruit a Senior Quality & Regulatory Affairs Specialist. The role focuses on maintaining cross‑border regulatory compliance and quality systems across Australia, Europe, Japan and the USA, with hands‑on involvement in audits, CAPA and product development.

You will collaborate with leadership, engineering and product teams to ensure continuous improvement of QMS, regulatory submissions and post‑market

Qualifications

• Experience in medical device regulatory affairs and quality assurance.

Responsibilities

• Support Regulatory Affairs across Australia, Europe, Japan and the United States in line with EU MDR, MDSAP, TGA, FDA and PMDA requirements.

Skills

Regulatory affairs

Quality assurance

Audits

CAPA

Risk management

QMS

Regulatory submissions

Job description

An exciting opportunity has become available for an experienced Senior Quality & Regulatory Affairs Specialist to join an innovative Australian medical device company with products approved across Australia, Europe, Japan and the USA.

This is a rare opportunity to step into a broad QA/RA position within a collaborative and highly technical environment, where you'll work closely with leadership, engineering and product development teams while helping drive the next phase of growth.

If you enjoy being hands-on, solving problems, improving systems and seeing the direct impact of your work, this could be the ideal next step in your career.

About the Role

Reporting to the Head of Quality & Regulatory Affairs, you'll play an integral role in maintaining quality and regulatory compliance across multiple international markets while supporting upcoming audit activities and future product development initiatives.

This is a broad, hands-on role offering exposure across Quality Assurance, Regulatory Affairs, engineering, manufacturing and product development within a collaborative and highly technical environment.

Key Responsibilities

• Support Regulatory Affairs activities across Australia, Europe, Japan and the United States, ensuring ongoing compliance with applicable regulatory requirements.
• Prepare, review and maintain regulatory submissions, technical files and supporting documentation.
• Manage compliance activities in accordance with EU MDR, MDSAP, TGA, FDA and PMDA requirements.
• Support regulatory compliance for both hardware and software-based medical devices.
• Work closely with Engineering, R&D and Product Development teams to assess regulatory requirements associated with product changes and future technologies.
• Review, update and maintain Quality Management System (QMS) documentation, procedures and work instructions.
• Identify compliance gaps and drive corrective and preventive actions to support continuous improvement.
• Support supplier audits, external audits and surveillance audit activities.
• Contribute to CAPA, risk management, post-market surveillance and ongoing quality assurance initiatives.
• Liaise with internal stakeholders, external auditors and regulatory bodies as required.
• Provide practical quality and regulatory guidance to support compliance throughout the product lifecycle.
• Assist with audit readiness activities and support the organisation in preparing for upcoming regulatory and quality audits.

About You

To be successful, you will ideally have:

• Experience within the medical device industry, with exposure to Regulatory Affairs, Quality Assurance or both.
• Demonstrated EU MDR experience (essential).
• Experience supporting regulatory submissions, registrations and ongoing compliance activities.
• Knowledge of international medical device regulations, including TGA, EU MDR and ideally FDA and/or PMDA requirements.
• Experience maintaining technical documentation, technical files and quality system documentation.
• Familiarity with ISO 13485, MDSAP and medical device quality management systems.
• Experience supporting audits, quality system improvements and compliance initiatives.
• The ability to identify compliance gaps, assess risks and implement practical solutions.
• A hands-on, proactive approach with the ability to work independently in a small, collaborative team.

Highly Regarded

• Experience with orthopaedic, surgical, sterile or software-enabled medical devices.
• Exposure to both Regulatory Affairs and Quality Assurance functions.
• Experience supporting global medical device registrations and interactions with Notified Bodies or regulatory authorities.
• Experience working within a small or growing MedTech organisation.
• Exposure to supplier audits, CAPA, risk management or post-market surveillance activities.

Why Apply?

This is more than a typical Quality & Regulatory role. You'll gain exposure across the full product lifecycle while working closely with Engineering, R&D and senior leadership in a growing medical device business. In this role, you'll gain exposure to:

• Global regulatory activities across Australia, Europe, Japan and the USA.
• Quality Management Systems, audit preparation and continuous improvement initiatives.
• Product design, development and commercialisation activities.
• Close collaboration with Engineering, R&D and Product Development teams.
• Supplier management, external audits and international compliance requirements.
• Manufacturing, sterilisation and distribution processes within a regulated medical device environment.
• Next-generation product development, including future AI-enabled technologies.

What's on Offer?

• Competitive salary package.
• Hybrid working arrangements available following onboarding.
• Opportunity to join a growing Australian medical device company with products approved across Australia, Europe, Japan and the USA.
• Broad exposure across Quality Assurance, Regulatory Affairs, Engineering and Product Development.
• Opportunity to work on both hardware and software medical devices within a global regulatory environment.
• Significant ownership and visibility in a small, collaborative team.
• Exposure to future product development initiatives, including next-generation and AI-enabled technologies.
• Supportive leadership and the opportunity to work alongside highly experienced quality, regulatory and engineering professionals.
• Sydney Inner City location with excellent public transport access.