Responsible for the execution of all compliance activities, to ensure a sustainable state of compliance to applicable regulations, standards and internal policies and procedures.
Responsible for Medical Device's Compliance data gathering, analysis, reporting and communicating the output of the data analysis, trends and conclusions to Senior Management.
Responsible for supporting the development of the compliance strategies and execution of such strategies, the implementation of proactive compliance projects and Initiatives, Internal Audit program, as well as providing compliance guidance, including compliance support for Quality improvement and remediation activities.
Support New Product Development (NDP) projects as needed, Quality & Compliance activities, Technical File, Technical dossiers, Regulatory submissions, Registration, for targeted markets and per customers and organization's requirements.
Serves as the Regulatory compliance expert for cross site and cross segment's project teams consistent with company goals and objectives to improve overall compliance performance to established metrics and requirements.
Alert organization to any existing and potential problems and risks
Responsible for communicating business related issues or opportunities to next management level
May require contact with external functions such as Regulatory Agencies (e.g. FDA), and Notified Bodies (e.g. TUV, HSA).
Assist in formulating regulatory policies and procedures to be followed by company personnel in compliance with local, state, and federal regulations through the development of Standard Operating Procedures.
Keep abreast of new standards and regulations Responsible for maintenance and publishing of regular applicable regulatory update within the organization, compliance but not limited to CE, FDA, HSA, Food Safety.
Compilation of technical dossiers, technical files, regulatory submissions for target markets and per customers and organization's requirements.
Responsible for Product and establishment registration and maintenance for the groups of companies, including product recall.
Perform internal audits of processes, facilities and documentation to assure compliance with internal procedures, ISO 13485 / FDA 21 CFR Part 820 regulations, International standards, and customer specific regulatory requirements.
Work with purchaser for request with regards to updated regulation declaration / compliance letter from supplier to ensure used material comply to relevant customer, medical devices and food safety requirements.
Issue regulatory declaration / compliance letter to customers to ensure our product meets customer requirements.
Any other duties as and when assigned
Requirements:
Degree in Medical Devices, Biomedical, Biopharmaceutical or Pharmaceutical related
Minimum 2 years experience in Quality System - Internal/Lead Auditor
Knowledge of molding and assembly manufacturing process flow, inspection system, sampling technique and customer specific requirement.
Strategic thinker as it pertains to compliance programs with strong leadership ability, interpersonal, communication, and influencing skills
Ability to understand procedural documents and evaluate documents to ensure compliance with all applicable regulations and requirements
Operational Quality experience in at least one of the following areas: Medical Device, Biopharmaceutical or Pharmaceutical products
