Regulatory Assistant Manager/ Manager (Medical Device)
Recruit Express Pte Ltd| Date Posted: 4-Jan-2021
EA Licence No: 99C4599|EA Personal Registration No: R1763413
Diploma, Bachelor's / Honours, Masters / PhD
- To manage product registration and renewal activities of all countries where company's products are marketed in order to ensure compliance to regulations in a timely and effective manner
- To ensure that all product submissions comply with regulations and relevant international medical device agency standards.
- To provide regulatory advice on company’s business strategy and manage projects in the provisions of these regulatory affairs services.
- To perform the yearly Post Market Assessment for products in compliance with regulations and standards.
- 510K Pre-market Notification - to oversee and manage all product registration or change notification or renewal activities for the company to ensure that the company is eligible to sell the products in relevant countries.
- To handle the specific product registration activities in EEA, Malaysia, Indonesia, Korea and new emerging markets in order to ensure compliance to regulations and products are marketed legally
- To ensure regulatory compliance by completing the appropriate filings and documentation pertaining to the company’s product registration/approvals, as required by internal procedures relating to Singapore and International regulatory requirements.
- To manage the control of documents and records, artworks, technical files, IFUs, test reports and other pertinent documents in the library in order to ensure records are not damaged, lost, deteriorated or unintentionally disposed
- To monitor and manage Document Control staff on document control activities in order to maintain company documentation, security, change control, requisition, distribution and control.
- To guide the Regulatory Department in its day to day work in order to ensure that all product submissions comply with the regulations of Health Science Authority of Singapore and other relevant International Medical Device Agency, e.g. US FDA, etc.
- Min. Degree in any science or technical field
- Minimum 3 years’ quality or regulatory related experience in a medical device or GMP regulated industry/ Minimum 3 years in supervisory or management role
- ISO 13485 certified. MDSAP certified.
- Understanding of MDSAP, EU MDR 2017/745, MDD 93/42/EEC, ISO 13485 requirements and ISO 9001 requirements.
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Alex Goh Hock Leong (Alvin)
Recruit Express Pte Ltd
EA Licence No. 99C4599
Recruit Express Pte Ltd