Quality Assurance Technician, Non-Union
Graham Packaging
Job Level
JuniorMid-Level
About the role
- Directs or performs coordination and preparation of document packages for regulatory submissions
- Teams with other Regulatory Affairs Specialists and international regulatory specialists to provide regulatory support for changes to existing products
- Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies
- Leads or compiles all materials required in submissions, license renewal and annual registrations
- Supports change control activities to support global approval and implementation of product and process changes
- Recommends changes for labelling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance
- Keeps abreast of regulatory procedures and changes
- Develop internal procedures to ensure continuous compliance with all regulatory requirements
- May direct interaction with regulatory agencies on defined matters
- Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed
- Monitors and improves tracking/control systems
- Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives
Requirements
- Qualified to Level 8 Science or Engineering honours bachelor’s degree
- Minimum of 2 years of relevant experience
- Regulatory experience in Medical Devices and/or Pharmaceuticals is required
- Regulatory Affairs qualification is desirable, but not mandatory
- Dynamic team player and can work effectively and proactively individually and in teams
- Strong technical knowledge
- Skilled in thinking critically and making sound decisions
- Collaborate with others and create alignment with team members
- Set high standards and drive accountability
- Model ethical behaviour
- Ability to work independently and under general direction only
- Strong proficiency skills with I.T systems and data collection
