Regulatory Affairs Officer

**ESSENTIAL DUTIES but not limited to: -**
- Initiate, track and facilitate new registrations of medical devices into a relevant registration authority with a focus on the Australian Register of Therapeutic Goods
- Manage change to the existing products to ensure registrations remain valid and accurate
- Manage accurate hard copy and electronic versions of technical files for all listed/included products. For products manufactured by the client, create and maintain the files. For sponsored products, ensure up to date documentation is on site as per the requirements or available from supplies when requested by relevant registration authorities (e.g. TGA)
- Maintain the ERP database to cross-reference item numbers with the listing/inclusion number
- Develop and maintain an effective working relationship with relevant bodies (e.g. TGA)
- Organize appropriate payment of fees to relevant bodies (e.g. TGA) according to the company’s registration requirements
- Advise on regulatory requirements for special projects
- As required, assist the Contract Manager with regulatory response to tender submissions
- Manage customer requests for regulatory information in a timely manner in consultation with the Head of Quality, co-ordinate efficient use of outside consultants where required for projects
- Conduct internal audits on processes under the quality system
- Contribute to the update of the Quality Manual
- Advise the company on any recall activities and co-ordinate any recall or non-recall actions
- Keep up to date with regulatory changes which affect the company’s products and provide advice as necessary to ensure that the company remains in compliance with the relevant requirements
- Communicate in an effective manner to all levels of the organisation
- Review artwork files for regulatory compliance
- Review manufacturing documents for regulatory compliance

**SUPERVISORY RESPONSIBILITIES**
- Provide guidance to non-regulatory staff members on requirements

**QUALIFICATIONS**
The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
**EDUCATION and/or EXPERIENCE**
The entry requirements for this occupation are:

- Qualification in a health-related discipline
- At least 2 years of experience in an Australian or European health related regulatory position

**COMMUNICATION SKILLS**
- Demonstrated ability in business to government liaison.
- Ability to write, read, analyse, and interpret complex documents
- Ability to respond effectively to sensitive inquiries or complaints
- Ability to present persuasive and cogent argument to management and peers
- Ability to translate government documents into the client's organizational environment

**Salary**: $70,000.00 - $75,000.00 per year

Schedule:

- 8 hour shift

Ability to commute/relocate:

- Villawood, NSW: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- Supervisor: 2 years (preferred)
- Health Regulatory: 2 years (preferred)

Licence/Certification:

- Triple Covid Vaccination (preferred)

Work Authorisation:

- Australia (required)