Regulatory Affairs & Quality Assurance Associate at Zimmer Biomet, Sydney, Australia

Regulatory Affairs & Quality Assurance Associate at Zimmer Biomet – Sydney, Australia

Zimmer Biomet Jobs Australia offers an opportunity for professionals interested in medical device regulatory affairs, quality assurance and healthcare compliance. Zimmer Biomet Pty Ltd has been associated with a Regulatory Affairs & Quality Assurance Associate vacancy in Sydney, New South Wales, Australia.

This full-time, hybrid role focuses on regulatory documentation, product registrations, quality management systems and post-market activities for medical technologies across Australia and New Zealand.

The Regulatory Affairs Associate position may suit candidates with a background in pharmaceutical sciences, medical devices, life sciences, healthcare, engineering or another relevant scientific discipline who want to develop their careers in a regulated healthcare environment.

Important: This role primarily concerns medical devices and medical technology, rather than pharmaceutical drug manufacturing. Applicants should confirm that the vacancy is still open before applying.

Job Details

• Company: Zimmer Biomet Pty Ltd
• Job Title: Regulatory Affairs & Quality Assurance Associate
• Location: Sydney, New South Wales, Australia
• Job Type: Full-time
• Work Arrangement: Hybrid
• Industry: Medical Technology, Healthcare and Regulatory Affairs
• Experience: Relevant regulatory affairs or quality experience preferred
• Salary: Not disclosed in the available listing
• Focus Keyword: Regulatory Affairs Associate
• Job Category: Australia Pharmaceutical Jobs / Medical Device Regulatory Affairs Jobs
• Application Status: Verify current availability

About Zimmer Biomet

Zimmer Biomet is a medical technology company that develops products and solutions used in orthopaedics and related healthcare fields. Regulatory affairs and quality assurance functions are important for supporting product compliance, documentation accuracy, product safety and applicable regulatory requirements.

In this position, the associate may work with local, regional and global colleagues to coordinate regulatory activities and maintain quality documentation for products supplied to the Australian and New Zealand markets.

For candidates exploring a Regulatory Affairs Associate career, this role may provide exposure to product lifecycle management, regulatory submissions, quality systems and post-market compliance.

Key Responsibilities

1. Regulatory Affairs and Product Registration

The successful candidate may support regulatory activities for an assigned portfolio of medical devices and related technologies.

Responsibilities may include:

• Preparing and coordinating regulatory submission documentation.
• Supporting product registrations, renewals and variations.
• Maintaining regulatory records, approval documents and submission trackers.
• Assisting with product lifecycle management activities.
• Monitoring relevant regulatory changes and communicating potential impacts.
• Escalating submission delays, compliance concerns and regulatory issues to senior colleagues.

These activities require strong organisational skills, attention to detail and the ability to work with controlled documentation. A Regulatory Affairs Associate should also be comfortable coordinating information across multiple teams and working to regulatory deadlines.

2. Quality Assurance and Quality Management Systems

The position may also support selected quality assurance activities and the maintenance of quality management system documentation.

Potential responsibilities include:

• Assisting with audit preparation and supporting records.
• Maintaining controlled quality documents and regulatory evidence.
• Supporting supplier documentation reviews.
• Assisting with quality procedures and document updates.
• Coordinating relevant complaint documentation.
• Supporting applicable corrective and preventive action activities under established procedures.

Candidates interested in a Regulatory Affairs Associate role should understand the importance of accurate records, document control, traceability and compliance with approved procedures.

3. Post-Market Surveillance

Post-market surveillance helps organisations monitor product performance and safety after products are made available to customers.

The associate may support complaint records, adverse-event documentation, field safety action coordination and relevant reporting requirements.

These activities require timely documentation, accurate communication and appropriate escalation of potential product safety concerns. Applicants with experience in regulated healthcare products or post-market quality processes may find this experience relevant to their career development.

4. Cross-Functional Collaboration

The role may involve collaboration with regulatory affairs, quality assurance, commercial, supply chain, technical and other internal teams.

Effective coordination helps ensure that regulatory records remain accurate, product changes are appropriately managed and compliance requirements are communicated to the relevant stakeholders.

For a Regulatory Affairs Associate, the ability to communicate clearly, manage priorities and collaborate with different functions is important.

Qualifications and Experience

Candidates interested in the Regulatory Affairs Associate vacancy should review the employer’s complete job description for mandatory selection criteria.

The relevant candidate profile may include:

• A degree in science, healthcare, engineering or a related discipline.
• Relevant experience in regulatory affairs, quality assurance or a regulated healthcare environment.
• Strong written and verbal communication skills.
• Excellent attention to detail and documentation accuracy.
• The ability to organise records and manage competing deadlines.
• Familiarity with Australian and New Zealand regulatory requirements.
• Strong analytical thinking, teamwork and stakeholder coordination skills.

Experience with medical device regulations, product registrations, quality management systems and post-market surveillance may be advantageous.

Professionals transitioning from pharmaceutical quality assurance or regulatory affairs may have transferable skills. However, medical device regulatory requirements differ from those for medicines, so applicants should assess the role’s specific expectations.

Salary and Benefits

The salary for this Regulatory Affairs Associate vacancy was not disclosed in the available listing reference. Candidates should check the current employer advertisement for updated compensation details, benefits and employment conditions.

The position is described as full-time with a hybrid working arrangement in Sydney. The exact office attendance requirements, benefits and other employment terms should be confirmed directly with the employer.

Why Consider This Opportunity?

This opportunity may interest professionals seeking experience in medical device regulatory compliance, quality systems and product lifecycle management.

A Regulatory Affairs Associate role can help develop practical skills in regulatory documentation, submission coordination, post-market activities and collaboration with quality and technical teams.

The Sydney location may also be relevant to candidates exploring healthcare and medical technology careers in Australia. Applicants should consider their qualifications, relevant experience and long-term career goals before applying.

How to Apply

Interested candidates can review the vacancy using the links below.

APPLY Now

Primary application link:
https://careers.zimmerbiomet.com/us/en/job/ZBUZBRUS12719EXTERNALENUS/Regulatory-Affairs-Quality-Assurance-Associate

Alternative job search:
https://au.seek.com/pharmaceutical-regulatory-affairs-jobs/in-All-Australia

The first link was provided as the employer application reference for this vacancy, but applicants should confirm that it remains active and that the job details match the Sydney position. The SEEK link is a broader job-search page, not a direct application link to this specific role.

Before applying, prepare an updated CV highlighting relevant regulatory documentation, quality assurance, audit support, product lifecycle management and medical device or healthcare compliance experience.

Frequently Asked Questions

1. Where is the position located?

The vacancy is reported in Sydney, New South Wales, Australia, with a hybrid working arrangement.

2. Is this a pharmaceutical manufacturing job?

No. It is primarily a medical technology and medical device regulatory affairs and quality assurance position.

3. What qualifications are relevant?

A degree in science, healthcare, engineering or a related discipline may be relevant. Check the employer’s full advertisement for the required qualifications and experience.

4. Is the salary disclosed?

The salary was not disclosed in the available listing reference.

5. How can I apply?

Use the employer application link above and verify the current vacancy status. If the link is inactive, search the official Zimmer Biomet careers website for the job title.

Disclaimer

This article is published by Pharmaguidances for informational and career-awareness purposes. Job details, eligibility criteria and application status may change without notice. Pharmaguidances is not affiliated with or endorsed by Zimmer Biomet. Applicants should verify all information and submit applications only through legitimate recruitment channels.