Regulatory Affairs & Quality Assurance Manager

Job description

Join a global player in the In Vitro Diagnostic industry as a Regulatory Affairs and Quality Assurance Manager where you'll play a key role in supporting RA/QA functions and driving innovative healthcare solutions.

In this dynamic position, you’ll prepare regulatory submissions, ensure adherence to local and international standards, and collaborate with diverse teams to manage critical regulatory and quality activities effectively.

Responsibilities:
• Responsible for developing and shaping their RA/QA strategy, ensuring alignment with the organisation's goals. Provide strategic leadership, make critical decisions, and allocate resources to execute and drive the successful implementation of the strategy while monitoring its progress and adapting as needed
• Use your expertise to manage areas of regulatory ambiguity that provide the most favorable outcome for the organization, whilst taking into account risk/reward situations
• Develop relationships with QA and RA teams and key influencers
• Drive the Quality Assurance program to maintain the Conformity Assessment Certificate to manufacture according to ISO13485 as well as adherence to ISO+001, ISO14+71 and the Australian Medical Device Regulations
• Develop and update departmental procedures aligned with document control standards, ensuring all documentation is current and compliant.
• Translate regulatory requirements into actionable submission plans and manage submission timelines.

Your skills and experience:
• Bachelor’s life science degree or equivalent experience required.
• Prior experience as a Regulatory Affairs Specialist / Manager in a similar field (Medical Devices / IVD)
• Experienced in ISO 13485 / +001 / 14+71
• Background working with a company that manufacture products themselves - experience in whole product lifecycle

At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.

skills

Regulatory Affairs & Quality Assurance Manager

qualifications
• ISO - 13485 / +001 / 14+71
• IVD / Medical Device experience in a Medical company that manufactures products in-house

education

Bachelor Degree