• Our Client is a well-established Medical devices industry.

Responsibilities: 

• 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. 

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.

Other Information:

• 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 novita.tan@gmprecruit.com
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