Regulatory & Quality Associate
2 weeks ago
**Roles and Responsibilities**
1.Support the senior engineers, quality, and regulatory compliance advisors in Medtech projects.
Project such as:
- Product technical documentation or technical file preparation on medical device such as engineering testing report, engineering product specifications, harmonised standards on the relevant medical device safety and performance as well as risk analysis related to product design, manufacturing, clinical & usability.
- Quality management system preparation and implementation for certification for medical device manufacturer and/or distributor such as design control procedures, manufacturing and quality process, statistics for sampling, and installation & distribution procedures
- Product registration with country dossier preparation from the product technical documentation & Quality Management system for Singapore HSA, CE, and global registration.
2. Support company administrative activities assigned to team related to medical device business.
3. Support on marketing, sourcing, and control management of resources (business, financial, human resource, facility)
4. Support in projects by understanding client needs, strategy planning, preparation of required documents or sourcing of information, tracking of status and communication to client for timely completion of projects.
Project such as:
- Business process documentation preparation and implementation
- Marketing information related to medical device
- Quality management system preparation and implementation for certification
- Product technical documentation preparation
- Product registration with country dossier preparation for world-wide submission, including new products, change/variation & renewals to the relevant authorities
- International Medical Device School training program activities
**Requirements/Qualifications**
- Bachelor's degree majoring in Pharmacy, Regulatory or related fields.
- Minimum 1 year experience.
- Skills - Technical Documentation, Usability, Sampling, Regulatory Compliance, Product Design, Quality Management, Quality Assurance, GMP, Investigation, Human Resource, Design Control, Business Process, Regulatory Requirements, Disposition, Strategy Planning, Manufacturing
Pay: RM2,200.00 - RM3,200.00 per month
Schedule:
- Monday to Friday
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