About The Company

Our client is a Perth-based company that is experiencing continued growth.

The company is entering an exciting stage of growth and needs to bolster their Regulatory Affairs team with a Regulatory Affairs Associate with strong project management skills.

The Role

Reporting to the Director, Regulatory Affairs, this role will lead regulatory activities for a number of projects, ensuring regulatory requirements, risks and deliverables are effectively managed and aligned with commercial objectives, project milestones and launch timelines.

Key Responsibilities

The key responsibilities of this role include:

- Serve as the Regulatory Affairs lead for assigned strategic projects.

- Develop and implement regulatory strategies to support project delivery.

- Ensure regulatory activities are incorporated into project plans and stage-gate processes.

- Provide regulatory guidance on new products, technologies, claims and market opportunities.

- Partner with Commercial, R&D;, Quality and Supply Chain teams to support project execution.

- Identify, communicate and manage regulatory risks and mitigation plans.

- Support market access, submissions, notifications and regulatory approvals as required.

- Monitor relevant regulatory developments and assess their impact on future projects.

About you

We are looking for someone who combines robust project management experience with knowledge and experience in regulatory affairs and a practical and solutions-focused approach.

Skills and Experience

- Degree in a relevant scientific discipline.

- Experience in Regulatory Affairs within a regulated industry.





- Strong project management and stakeholder engagement skills.

- Ability to translate regulatory requirements into practical business solutions.

- Strong communication, planning and problem-solving capabilities.

Success Measures

- Delivery of regulatory project milestones on time.

- Successful support of product launches and business initiatives.

- Effective management of regulatory risks.

- Positive stakeholder feedback and cross-functional collaboration.

Interested?

If you are an experienced medical-device quality and regulatory professional looking for a role where your expertise can have a direct impact on the development and commercialisation of an innovative medical technology, we would like to hear from you.

If you are interested in a new and exciting career move and you feel you meet the requirements for the role, please send your CV and a cover letter to ••••@biotechrecruitment.com.au so that we can arrange a confidential discussion about this role.

About Biotech Recruitment Consultants

Biotech Recruitment Consultants is a niche recruitment company specialising in executive search and recruitment for the broader biotechnology industry (including pharma, medtech, biologics, etc).

We recruit for biotech, life science and healthcare roles worldwide and aim to provide personalised service for both clients and candidates.

Our website (www.biotechrecruitment.com) provides more information on how to apply for jobs, register your CV, view some of the jobs that we are currently recruiting for, or simply to get in contact with us.

📌 Regulatory Affairs Associate - Projects (Perth)
🏢 Biotech Recruitment Consultants
📍 Perth