Regulatory Affairs Specialist

All vacancies of Australia • Healthcare & Medical • Regulatory Affairs Specialist

Provide Regulatory Affairs expertise to an exciting and growing Medical Devices/Diagnostics business across the entire product lifecycle

Summary about this job

Pharmaceuticals & Medical Devices

Company: Hobson Prior Australia

Location: Sydney

Work type: Full Time

Salary: n\a

Phone: +61-7-2962-4183

Fax: +61-3-7043-3328

E-mail: n\a

Site: n\a

Detail information about job Regulatory Affairs Specialist. Terms and conditions vacancy

Australian business with international focus
Cutting edge technology
Rapidly growing company

About the business and the role

An Australian Medical Device/Diagnostics business. This role will be responsible for multiple areas of the product lifecycle. They are a business that have a cutting edge facility and a really strong pipeline of new products coming through

Job tasks and responsibilities

Responsibilities: -

Registering and submitting product applications
Work closely with the Product Development Team to incorporate RA changes and requirements - serve as the RA representative for the company in this area.
Develop plans to implement regulations that have a significant impact on the business.
Execute CE Mark submissions as well as TGA submissions
Represent the company for RA related issues

Skills and experience

Experience: -

5+ years experience of working in a regulatory role in the medical device industry specifically with CE Mark submissions
A thorough understanding of medical device regulations and the product lifecycle
Experience working with international Regulatory Bodies would be ideal

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