Senior Regulatory affairs Specialist

Our client is an international Medical Device organisation who are a household name across various specialty and product areas including Cancer Diagnostics
 
They offer fantastic training and onboarding and there are plenty of opportunities for career development and progression within the organisation.

Position Overview:

This position has been newly developed within the Regulatory team due to an internal promotion within the current Regulatory team. 

Responsibilities:

• Lead global regulatory strategy for new products and significant product changes
• Product change reporting and compliance assessments including review and approval of labelling, advertising and promotional material for compliance to applicable regulations.
• Representation of Regulatory Affairs in external audits including FDA pre-approval inspections.
• Establish and maintain strong relationships with internal and external stakeholders

Desired experience:

• Bachelor’s degree preferably in science, medical or engineering.
• Minimum 5 years Regulatory Affairs experience in medical devices required, IVD instruments experience highly desirable.
• Lead assessment and implementation of complex regulations.
• Proven cross-site, cross-functional business partnering.

What's on offer:

• Competitive Base salary + Super
• Plus Bonus 
• Hybrid work from home 

 To apply for this role, please reach out to Nicola Davison on 0401224744

nicola.davison@onemd.com.au