Risk Management Medical Device jobs

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

About the Role

We’re looking for an experienced Medical Writer to join our ANZ team and play a key role in shaping high-quality scientific and regulatory content. In this role, you will lead the development of Clinical Evaluation Reports (CERs) to support regulatory submissions for orthopaedic devices and technologies across Australia and New Zealand. You will also prepare and manage post-market surveillance documents and contribute to a range of scientific publications, including journal manuscripts, conference abstracts and white papers.

This role is ideal for someone who thrives on scientific communication, enjoys working across cross-functional teams, and is confident in translating complex clinical data into clear, accurate and engaging content for both internal and external audiences.

Key Responsibilities

• Develop and maintain Clinical Evaluation Reports (CERs) in line with TGA requirements, EU MDR (2017/745) and Zimmer Biomet internal standards, drawing on clinical research, peer-reviewed literature, risk management files and post-market data.
• Conduct structured literature reviews to support post-market surveillance (PMS) reports.
• Prepare scientifically robust responses to regulatory queries, ensuring accuracy and alignment with regional and global standards.
• Circulate final draft reports for review and approval across Clinical Affairs, Regulatory Affairs, Post-Market Surveillance and Engineering teams.
• Support audit activities and serve as a subject matter expert (SME) as required.
• Explore and adopt innovative medical writing approaches, including the use of advanced writing tools and AI, to improve efficiency and output.
• Develop, write and edit manuscripts for peer-reviewed journals, ensuring clarity, scientific integrity and adherence to journal guidelines.
• Create conference abstracts, posters and presentation materials in collaboration with internal experts.
• Prepare white papers, technical summaries and evidence-based narratives to support product value messaging and thought leadership.
• Collaborate with Clinical Affairs, Regulatory, R&D and Marketing teams to gather insights, ensure accuracy and support strategic communication initiatives.
• Manage multiple projects, deadlines and submission workflows simultaneously.
• Support publication planning and broader scientific communication strategies.

What We’re Looking For

Qualifications & Experience

• Bachelor’s degree in a scientific, medical or health-related discipline (e.g., life sciences, biomedical engineering).
• Postgraduate qualifications (MSc, PhD, PharmD) preffered
• Minimum 3 years’ experience in medical writing, ideally within the medical device, pharmaceutical or healthcare sectors.
• Demonstrated experience producing manuscripts, abstracts or white papers for scientific or clinical audiences.

Skills & Competencies

• Strong understanding of medical device regulatory requirements, including TGA and EU MDR.
• Solid knowledge of clinical research methodologies and medical terminology.
• Ability to critically evaluate and interpret clinical data.
• Familiarity with publication processes, journal requirements and best practice guidelines (e.g., ICMJE, GPP).
• Excellent written, editorial and verbal communication skills.
• Ability to work independently while contributing effectively within cross-functional teams.
• Strong organisational skills with the ability to manage competing deadlines.
• Proficiency with Microsoft Office and reference management tools such as EndNote.

EOE/M/F/Vet/Disability