- Our Client is a well-established Medical devices industry.
- Product Registration Management.
- Regulatory Affairs Management.
- Document Control.
- Post Market Assessment.
- 510K Pre-market Notification.
- 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.
- To manage and ensure compliance on product registration and renewal activities of all countries where Company's products are marketed.
- 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 both contact lens and lens care products as required by regulations and standards.
- To perform 510K pre-market notifications for products registered in relevant countries.
- To handle the specific product registration activities in EEA, Malaysia, Indonesia, Korea and new emerging markets as and when required.
- 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.
- Bachelors' Degree in Science or relevant discipline.
- ISO 13485 and MDSAP Certified.
- Minimum 3 years' experience in Quality or Regulatory, from Medical device or GMP regulated industry.
- Understanding of MDSAP, EU MDR 2017/745, MDD 93/42/EEC, ISO 13485 requirements and ISO 9001 requirements.
- Understanding of related Regulatory and cGMP requirements.
- Understanding of Product Registration, Trademark and CE Mark.
- Good communications and interpersonal skills.
- Results-oriented, meticulous and a self-motivated team player.
- Working Location: East.
- Working Hours: Mondays to Fridays, 8.30am to 5.30pm.
- Critical: Due to the organization's affirmed support and commitment to developing a Singaporean core, this role is only available to Singaporeans.
To apply, please visit www.gmprecruit.com and search for Job Reference: 18480.
To learn more about this opportunity, please contact Novita Tan at firstname.lastname@example.org
We regret that only shortlisted candidates will be notified.
GMP Recruitment Services (S) Pte Ltd | EA License: 09C3051 | EA Personnel: Novita Tan | Registration No: R1220374