Regulatory Affairs Specialist – 12 Month Fixed Term Contract
Cook Group
contract
Posted on:
Location Type: Office
Location: Eight Mile Plains • Australia
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About the role
- Prepare Medical Device Files for submission to regulatory authorities, with a focus on European Notified Bodies
- Maintain Medial Device Files and other regulatory documentation
- Maintain regulatory license databases and systems which contain regulatory approval or restriction information
- Liaise with relevant departments at Cook Australia and at other Cook sites, as necessary, to understand and collate information required for regulatory submissions
- Communicate with regulatory agencies and conformity assessment bodies
- Provide regulatory support to engineering projects, as necessary
- Review global marketing materials for compliance to relevant advertising guidelines
- Perform administrative tasks, including document formatting, and preparing documentation for the internal change control process.
Requirements
- Tertiary qualification in a technically related field i.e., Science, Engineering etc. essential.
- Experience working in a highly regulated industry such as medical devices desirable
- Experience preparing regulatory submissions desirable
- An understanding of quality control / assurance in a manufacturing environment essential.
- Critical thinker, encourage innovation and continuous improvement
- Demonstrated ability to meet deadlines, balancing multiple priorities, and ensuring quality standards
- Highly organised with a focus on attention to detail
- Personal accountability with a process efficiency focus
- Effective problem-solving skills.
Benefits
- Work from home 1-3 days per week
- Base salary plus performance-based quarterly bonus and annual leave loading
- Prioritise your physical and mental wellbeing with access to onsite gym and our employee assistance program
- Subsidised cafeteria, wellness room and prayer room
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionsquality controlquality assurancedocument formattingregulatory documentationregulatory license databasesmedical device filesadministrative taskscompliance guidelinesengineering support
Soft Skills
critical thinkinginnovationcontinuous improvementtime managementattention to detailpersonal accountabilityprocess efficiencyproblem-solvingorganizational skillsability to meet deadlines
Certifications
tertiary qualification in Sciencetertiary qualification in Engineering