Asst. Regulatory Affairs Manager, Medical devices (MDSAP Certified, $5.2K)

☞ GMP Recruitment

View: 106

Location: East

Category: Other

Industry:

Position: Senior Executive

Job type: Full-Time

Salary: 4500 - 5200 SGD / month

Experience: 5 years

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Job content

  • 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 [email protected]
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
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