Regulatory Affairs Specialist
Looking for an enthusiastic Regulatory Affairs Specialist to join our RA team at our time of growth.
Summary about this job
Pharmaceuticals & Medical Devices
Company: Nanosonics Limited
Location: Sydney
Work type: Full Time
Salary: n\a
Phone: +61-2-9801-4542
Fax: +61-7-2313-3834
E-mail: n\a
Site: n\a
Detail information about job Regulatory Affairs Specialist. Terms and conditions vacancy
Nanosonics Limited is a publically listed ASX200 Australian medical device company. We develop, manufacture and commercialise innovative medical device disinfection solutions for global markets.
Our Company's mission is to improve the safety of patients, clinics, their staff and the environment by transforming the way infection prevention practices are understood and conducted by introducing innovative technologies that deliver improved standards of care.
We are currently seeking for a Regulatory Affairs Specialist to join our RA team. This is an excellent opportunity for a motivated regulatory affairs specialist to join a growing medical device company.
The ideal candidate will have previous experience in a regulated industry. Previous quality auditor experience will be highly regarded but not essential.
The main responsibilities of the role include:
- Create, maintain and coordinate technical files for products and accessories
- Coordinate regulatory submissions, technical dossier for products in different markets, maintain product licenses for current product portfolio
- Working closely with the R&D team, identify and implement product regulatory requirements, whilst complying with QMS requirements
- Liaise with external parties such as regulatory authorities and relevant industry bodies on all regulatory matters
- Be a champion for regulatory requirements and guidelines; contribute technological knowledge to implement regulatory strategies for any future products
To be successful in the role, you will need:
- Tertiary qualifications in Regulatory Affairs, Engineering, Science or related discipline
- Previous experience in a highly regulated industry essential
- Previous experience in project management and quality auditing will be highly regarded
- Strong working knowledge in MS Office and Adobe CS
- Strong verbal and written communication skills
- Strong integrity and work ethic
- Shows initiative, able to work independently and as part of a team
To submit your application, please submit your resume via Seek. Please note that only shortlisted applicants will be contacted.
**No Agencies thank you, we have this role covered**