HeraMED is an Australian-Israeli medtech company expanding healthcare technology solutions in Australia through digital maternity care and remote patient monitoring systems integrated with Telstra Health.
A Regulatory Affairs Specialist ensures that medical devices and digital healthcare products meet government regulations and safety standards before they are released to the market. They prepare regulatory documents, support product approvals, monitor changes in healthcare laws, and help the company maintain compliance with industry requirements.
Key Responsibilities
- Prepare and submit regulatory documents for product approvals.
- Ensure products comply with healthcare regulations and quality standards.
- Maintain regulatory records and product documentation.
- Monitor changes in healthcare laws and regulatory requirements.
- Work with product development, quality, and clinical teams to ensure compliance.
- Support internal and external regulatory audits.
- Review product labels and marketing materials for regulatory compliance.
- Communicate with regulatory authorities regarding product approvals.
- Identify regulatory risks and recommend corrective actions.
- Provide guidance to staff on regulatory policies and procedures.
Pay: From $10,000.00 per month
Benefits:
- Childcare assistance
- Company car
- Dental insurance
- Extended annual leave
- Health insurance
- Life insurance
- Parental leave
- Professional development assistance
- Relocation assistance
- Vision insurance
Work Location: In person
