Medical Device Regulatory Specialist
4 days ago
This role offers an exciting opportunity to join a dynamic team in the medical device sector. As a Regulatory Affairs Specialist, you will play a crucial part in ensuring compliance with regulatory standards and guidelines.
Your responsibilities will include collaborating with cross-functional teams to develop regulatory strategies, preparing and submitting regulatory documents, and reviewing submission materials for scientific integrity.
You will also be responsible for advising global regulatory teams on local compliance needs, partnering with marketing to review promotional content, and maintaining a thorough understanding of relevant laws and regulations.
In addition, you will monitor emerging regulations, drive process updates, secure additional regulatory authorizations as needed, and provide timely regulatory intelligence to leadership and cross-functional teams.
To succeed in this role, you will need a degree in science or a related field, at least 2-3 years of experience in regulatory affairs, and a solid understanding of both Australian and international regulatory frameworks.
You should also have exceptional verbal, written, and interpersonal communication skills, the ability to work autonomously and collaboratively, and a mindset geared towards innovation and continuous improvement.
About This Role- This is a full-time position that requires a high level of attention to detail and the ability to manage multiple projects simultaneously.
- You will have the opportunity to work closely with cross-functional teams to develop and implement regulatory strategies.
- You will also be responsible for reviewing and evaluating submission materials to ensure alignment with regulatory standards.
This role is ideal for someone who is passionate about regulatory affairs and has a strong understanding of relevant laws and regulations.
You will have the opportunity to work in a dynamic environment and contribute to the success of our organization.
What We Offer- A competitive salary and benefits package.
- The opportunity to work in a dynamic environment and contribute to the success of our organization.
- Ongoing training and professional development opportunities.
We are an equal opportunities employer and welcome applications from diverse candidates.
Please note that we do not discriminate based on age, gender, race, religion, or any other characteristic.
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