Brandwood Biomedical is a leading consultancy based on the lower north shore in Sydney – providing technical, regulatory and commercial advisory services to our clients who are primarily from the Medical Devices and IVD industry.
Our services support the whole product life-cycle, from investment readiness and due diligence to development and implementation of global regulatory strategies. Key service areas include Australian and International medical device sponsorship, agency services, post-market reporting, advertising and labelling compliance, clinical evaluations, expert technical reports and quality systems compliance.
Due to continuing growth in our client base, we are seeking to expand our team with a Senior Consultant to support our growing client services in Australia, China and South East Asia. The successful candidate will be working as part of the Brandwood Biomedical team to:
- Provide consulting services in relation to Quality Management Systems and Regulatory compliance under the direct supervision of the General Manager;
- Provide support to team members in client related consulting projects;
- Interface with clients;
- Determining the specific regulatory, technical and quality management outcomes needed for the commercial success of the client;
- Advise on, coordinate and prepare documents, reports, regulatory submissions and quality management documents.
- Be familiar and keep up to date with regulatory requirements in Australia, USA, European Union, and other markets where required;
Our ideal candidate will:
- Minimum of Bachelors Degree in relevant discipline (Science, Engineering)
- 5 + years in regulatory and/or quality management in medical device, diagnostics, biotechnology or consulting environment.
- Significant hands-on experience in the preparation of regulatory and technical submissions, reports and documentation.
- Broad understanding of local and international regulatory and compliance legislation and requirements.
- Prior experience in the implementation of quality management (ISO 13485:2003 and/or ISO 9001:2008) programs in a regulated (preferably medical device or diagnostics) environment.
- Background in managing medical compliance at a global or regional level is important; this experience could come from pharmaceutical, regulatory institution or consultancy, or medical device company
Experience in the Biotechnology and Healthcare industry is essential.
This is an exciting opportunity to join a leading Consultancy with considerable opportunity for development and for international experience located on the lower North Shore.
If you present with the skills and qualities above, please apply now by sending your resume and contact details to firstname.lastname@example.org.