Primary Purpose and Overall Objective of the Job:
Develop regulatory strategy of new launched products and ensure on time submission and approvals of complete regulatory application and files. Ensure quality compliance under applicable quality standards and bioMerieux corporate standards.
Main Accountabilities:
1) Regulatory Affairs
- Understand, investigate regulatory history of similar products in order to assess regulatory implications for new products or change to existing products.
- Ensure timely dossier preparation and submission to HSA for new products and product life cycle management.
- Stay abreast of regulatory changes and of application requirements and processes.
- Develop product regulatory strategy based on history of similar products with considerations to recent changes in requirements and propose solutions to meet them.
- Validate product labels, instructions for use, advertising and promotional materials in accordance to local regulatory requirements.
- Compile regulatory applications and files following existing procedures and documents organize content check regulatory applications and files for completeness and provide feedback ensure filing and timely approval.
- Assist in the execution of regulatory processes and interactions with regulatory agencies.
2) Quality Assurance
- Perform quality analysis on shipments (TTOR) after training and do the necessary release and coordination for shipment release as required for Singapore.
- Manager and coordinate internal & external audits and supplier audits.
- Perform/Support document control process including Standard Operating Procedure drafting, revision, publish and ensure periodic revisions are respected.
- Coordinate and monitor field actions implementation and complaint handling.
- Responsible to report Field Safety Corrective Action and Adverse event based on HSA guidelines.
- Manage and coordinate CAPA and vigilance activities.
- Communication in organization for Quality Management System performance and drive on continuous improvement opportunities.
- To carry-out other QA activities as required for the region such as digital tool roll-outs.
Typical Studies-Experience, Skills and Qualifications:
1) Studies-Experience:
- Bachelor's degree in science or engineering,
- Knowledge of MD/IVDMD regulatory requirements, processes and submission types (local/regional).
- Knowledge of ISO 9001:2015, GDPMDS SS60 Quality Management System requirements
2) Skills and Qualifications:
- Research information and data,
- Analyze and understand technical and scientific documents,
- Attentive to details and to consistency,
- Communication with internal stakeholders verbally and in writing,
- Can work in an international environment.
