- Our Client is a well-established Medical devices industry.
- To act as Person Responsible and RA Manager for Malaysia's Business Entity.
- Responsible to register, maintain and renew the product/establishment licenses to compliance to applicable regulatory authorities’ requirements.
- Manage and ensure compliance on product registration and renewal activities of all countries where Company's products are marketed.
- Provide regulatory advice on company’s business strategy and manage projects in the provisions of these regulatory affairs services.
- 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.
- 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.
- Minimum Bachelors Degree in Science or relevant Technical field.
- ISO 13485 and MDSAP Certified.
- Minimum 5 years' working experience in Regulatory Affairs, from Medical device or GMP regulated industry.
- At least 3 years Supervisory or Management experience.
- Understanding of MDSAP, EU MDR 2017/745, MDD 93/42/EEC, ISO 13485 and ISO 9001 requirements.
- Understanding of related Regulatory and cGMP requirements.
- Understanding of Product Registration, Trademark and CE Mark.
- Possess strong management and leadership skills.
- 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: 18808.
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