Senior Regulatory Affairs Specialist - Medical Devices

About the company

A rapidly expanding multinational company specialising in a key area within medical devices. Patients are at the heart of what they do, and quality is key. Driven by this desire to help patients, the company engages with some of the world's top clinicians and researchers to address unmet healthcare needs and improve patient outcomes and quality of life.

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About the opportunity

An opportunity has become available for a Senior Regulatory Affairs Specialist to join a family friendly and supportive team. You will be ensuring the submission of class III devices and conformity assessments as well as special access requests that require immediate action.

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Duties

• Class III device application & conformity assessments

• Provide expertise in Regulatory Affairs on special projects, the development of new concepts and all aspects of the product lifecycle process

• Immediate assessment of special access requests

• Liaise with all organisational levels, TGA and relevant Industry Bodies both locally and globally

• Full knowledge and understanding of country/ regions regulatory requirements for new products or product changes

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Skills and Experience

• Bachelor's Degree in related field

• 5 years' experience within Regulatory Affairs

• Class III device application & conformity assessment experience essential

• Excellent written & verbal communications skills

• Ability to prioritise and project manage

• Attention to detail

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Company Culture

A very supportive environment. Team meal is organised once a month and they pride themselves on being family friendly.

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How to Apply

Click apply or contact Madeleine Byrnes, Sourcing Consultant on 0288778703 for a confidential discussion.

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