Regulatory Affairs Specialist

Role profile: This role will be responsible for co-ordination of global regulatory submissions for in vitro diagnostic devices.

Responsibilities will include: 

• Partnering with global regulatory contacts to understand requirements for product registrations for new and modified products 

• Partnering with global regulatory contacts to plan, develop and submit product registration applications for new and modified products 

• Obtaining and maintaining documents required for global registrations such as Certificates to Foreign Government and Certificates of Free Sale. 

• Assisting with tracking of global registration status of all products. 

• As required, performing labelling reviews/approvals. 

• Researching and consolidating global regulatory requirements to enable future development of global regulatory strategies. 

• Assisting in the development of best practices for Regulatory Affairs processes