AddressA super exciting opportunity to join a start-up in the health tech industry. My client is looking for someone who is passionate about compliance, specifically ISO13485!
A bit more about the role
Reporting into the MD, the role leads and manages the quality and regulatory space within the business. You will ensure the the Quality Management System (QMS) complies with all applicable stands and regulatory requirements.
At a high level, you will
- Act as the designated Management Representative of the QMS and Compliance and Person Responsible for Regulatory Compliance
- Maintain the QMS in accordance with applicable standards and regulations
- Maintain the Quality and Product certifications as per Australian Medical Device Regulations 2002 and the European MDD and EU MDR
- Develop and maintain quality procedures, forms and work instructions
- Develop training modules and train employees on quality processes and cyber risk
- Conduct internal audits and participate in external audits
A bit about you
- Experience with regulated industry and experience working with certified QMS
- Exceptional attention to detail
- Excellent written and verbal communication skills
- Excellent organisational skills
- General undestanding of cyber and data compliance
- 4 years of experience in Regulatory Affairs or QMS on medical devises
- Relevant University Degree (law, medicine, pharmacy, engineering or another scientific discipline.)
HYBRID WORKING AVAILABLE.
Flexibility for either 4 or 5 days a week!
