facebook

Job details

Location
North Shore
Salary
AU$100000 - AU$110000 per annum + FTE
Job Type
Part Time
Ref
37099
Contact
Joanna Murphy
Contact email
Email Joanna
Contact phone
+61 2 88778718
Posted
30 days ago

Job details

Location
North Shore
Salary
AU$100000 - AU$110000 per annum + FTE
Job Type
Part Time
Ref
37099
Contact
Joanna Murphy
Contact email
Email Joanna
Contact phone
+61 2 88778718
Posted
30 days ago

About the company

An established medical equipment supplier to the medical and allied health sector in Australia. A broad product range and a global reach.

About the opportunity

This is a newly created position to provide support to the Regulatory Affairs Manager across the full regulatory function. The portfolio includes Class I, IIa, IIb, III medical devices. For an experienced Regulatory Affairs Specialist this will be a Part-Time position 0.6 FTE.

Duties

  • Manage dossier compilation for regulatory submission to the TGA/Medsafe and other associated bodies including AICIS
  • Maintain regulatory compliance of all products and ensure records are up to date
  • Provide guidance on regulatory strategy for new and approved products
  • Liaise with business partners and cross functional teams to provide support and guidance on regulatory requirements
  • Review and approve advertising and promotional materials ensuring compliance with advertising Codes.
  • Evaluate proposed product, labelling and manufacturing changes for regulatory filing solutions.
  • Maintain and build strong working relationships with relevant regulatory bodies, business partners, and cross-functional teams

Skills and Experience

  • 5+ years' experience for Regulatory Affairs Specialist: Part-Time position
  • Tertiary qualifiaction in relevant scientific discipline
  • Demonstrated success in analysis and interpretation of regulatory documentation and technical writing
  • Knowledge of TGA and Medsafe requirements for Medical Devices
  • Experience with management, compilation, submission, and maintenance or regulatory filings
  • Excellent communication and negotiation skills

Culture

A small company with a strong team spirit. Supportive and collaborative working environment and patient focused.

How to Apply

Click apply or contact Joanna Murphy, Specialist Manager - Regulatory Affairs & Quality Assurance on +61 2 8877 8718 for a confidential discussion.

Similar jobs

18 days ago

Regulatory Affairs

Regulatory Affairs Specialist

  • Broadmeadows, Victoria
  • Negotiable

BenefitsExcellent company cultureLeading pharmaceutical companyUndertake a role that will significantly improve the lives of patientsAbout the Company This large, global pharmaceutical company work collaboratively together to positively impact the lives of patients around the world. Their purpose and mission...

30 days ago

Regulatory Affairs

Senior Regulatory Affairs Associate

  • North Shore, New South Wales
  • Attractive salary package

Benefits Manage new registration applications and approvals, no maintenance work.Budget for Personal Development Training & ARCS MembershipSmall local company that is part of a large global organisation - you get the best of both worlds!About the company A small, local pharmaceutical co...

30 days ago

Regulatory Affairs

Regulatory Affairs Associate - Medica...

  • North Shore
  • super

About the companyAn established medical equipment supplier to the medical and allied health sector in Australia. A broad product range and a global reach. About the opportunityThis is a newly created position to provide support to the Regulatory Affairs Manager across the f...