Regulatory Affairs Associate Jobs Vacancy in Thermo Fisher Scientific Melbourne
Thermo Fisher Scientific Melbourne urgently required following position for Regulatory Affairs Associate. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.
Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.
Regulatory Affairs Associate Jobs Vacancy in Thermo Fisher Scientific Melbourne Jobs Details:
In this newly created role, you will report to the Regulatory Affairs and Quality Assurance Manager and have responsibility for ensuring compliance to Australian and New Zealand regulatory requirements. You will provide onsite support to the RAQA Manager, operations team, marketing team and product specialist teams as needed for new product introductions and maintenance of current product registrations.
The role will have an administrative focus and will assist with all regulatory functions as required.
- Provide interdepartmental Regulatory guidance
- Ensure regulatory compliance by updating company procedures and guidelines
- Maintain current product registrations and associated documentation and review for validity
- TGA medical device applications for inclusion into the ARTG
- Liaise with global regulatory teams across functional teams
- Gather necessary documentation for regulatory product registrations
- Provide Australian and New Zealand regulatory support to overseas suppliers
- Assist with product recalls
- Assist in producing training programs to communicate regulatory requirements
Specialist Skills & Knowledge:
- Working Knowledge of Australian and New Zealand regulatory requirements for medical device registrations
- Good understanding of current TGA Regulations and relevant ISO standards associated medical device registration process
- Ability to deal with pressure from many stakeholders and ability to work under tight deadlines
- Proficient in computer applications such as, Microsoft Word, Excel and PowerPoint
Qualification & Experience:
- Minimum two years local experience in regulatory affairs within medical device industry
- Previous experience dealing with TGA and Medsafe
- Demonstrated experience with TGA ARTG applications and maintenance of certificates
- Bachelor of Science or experience in health industry
- A self-motived team player
- Effective time management and the ability to work autonomously
- Strong team player with excellent communication skills
- Organized, structured, able to multi-task, dynamic and pro-active
- A strong desire to contribute to the growth of the company.
- A high level of personal integrity.