Regulatory Affairs Specialist
We are looking for a Regulatory Affairs Specialist to ensure regulatory compliance of documentation for submissions and be responsible for providing regulatory support during and after product regulatory approval.
With a background in science or engineering, you have strong documentation skills paired with technical ability and high attention to detail. You are known for your exceptional communication skills, both written and oral. You are able to manage your projects and workload independently while at the same time understanding how to collaborate and build relationship with your key stakeholders. You enjoy the prospect of bringing your skills to a company that prides itself on making a difference to people’s lives.
About Saluda Medical:
We are a medical device company developing advanced neuromodulation systems for the next generation of implantable stimulation devices. We are a cutting edge, progressive, 100% Australian company at the forefront of spinal cord stimulation technologies for the management of chronic pain.
Our team is made up of world-class engineers, clinicians and seasoned professionals with experience in bringing medical technologies to life.
About the role:
- Plan and organise regulatory documentation for product portfolio;
- Prepare regulatory submissions (e.g. Design Dossier, Change Notification, PMA Supplement) in line with regulatory requirements and guidelines;
- Coordinate the preparation of additional data/information requested by regulatory authorities and prepare appropriate responses to all such requests;
- Maintain and update product licences, certificates, and listings for existing product portfolio;
- Follow-up on the development of technical documentation required for regulatory submissions;
- Review technical documentation for accuracy and completeness to support regulatory submissions;
- Evaluate manufacturing and labeling changes for regulatory impact and accurately describe these changes for ease of regulatory agency review;
- Assist in preparation for meetings with regulatory authorities.
- Assist with development of labeling materials and review for compliance prior to release;
- Monitor and review updates to regulations, standards, and guidance documents to ensure ongoing compliance to regulatory requirements;
- Assist in the review of advertising and promotional materials in line with national regulatory requirements.
You will have:
- Tertiary qualification in a relevant science or engineering (e.g. biomedical, software, mechanical, electrical) related discipline;
- Demonstrated experience in the management, compilation, submission, and maintenance of large files (e.g. PhD, project filings, regulatory filings);
- Strong written and verbal communication skills;
- Effective time management and the ability to work autonomously;
- Self-motivated team player, with a high level of personal integrity;
- A strong desire to contribute to the growth of the company.
Ideally you will also have:
- Previous experience in medical device or other therapeutic goods industry, preferably in regulatory affairs;
- Experience working with cross functional teams;
- Understanding of medical device regulations and relevant ISO/IEC standards associated with the product development and approval process will be an advantage.
If you would like to be part of our team developing the world's next generation of implantable device technology, please apply now.
You must have the legal right to work unrestricted in Australia, no visa or sponsorship support is available for this role.
Candidates may respond to this posting; we respectfully ask for no agency approaches.