- 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.
- 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.
- 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.
- 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.
Requirements:
- Degree in Medical Device Engineering, Biomedical, or Pharmaceutical related fields
- Minimum 2 years experience in Quality System - Internal/Lead Auditor
- Knowledge of molding and assembly manufacturing process flow, inspection system, and sampling technique
- 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
- Mon - Fri (8:30am to 5:45pm)
- Salary package (Monthly salary + Transport Allowance + AWS + Variable Bonus)
We invite interested and qualified candidates to send in your updated resume (MS Word Format), stating your reasons for leaving each employment, your current and expected salary to and cc [Confidential Information]. Please indicate the position you are applying in your email subject. Your interest will be treated with strict confidentiality,
We regret to inform that only shortlisted candidates will be notified
EA License: 90C3627
EA Reg No: R1108020
