
Senior Quality Assurance and Regulatory Compliance Specialist
1 week ago
This is a fantastic opportunity to commence or extend your career in Regulatory Affairs/Quality Systems and join our team as a key player in global quality management.
About the RoleThe Regulatory Affairs and Quality Systems Associate Specialist reports to the Regulatory Affairs and Quality Systems Manager and supports all pre-market and post-market regulatory activities for existing products, whilst participating in quality related activities to ensure compliance to local and international regulations, legislation and standards.
Key Responsibilities:- Maintain Applied Medical's quality standards regarding its products, procedures, policies, operations, and customer contact;
- Act as liaison to customers, regulatory authorities, suppliers and internal teams and authorities;
- Manage projects to identify and implement systems to improve the Quality system and Regulatory compliance;
- Accurately process documents related to RA/QS;
- Create and update SOPs and Job Aids as required;
- Strong attention to detail and accuracy;
- Self-management, organisational and time management skills;
- Analysis and problem-solving skills;
- Excellent written and oral communication skills;
- Ability to work independently and collaboratively as part of a team;
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