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Jobs or company...

SENIOR REGULATORY AFFAIR EXECURIVE/ REGULATORY AFFAIR ASSISTANT MANAGER

RM 3,500 - RM 6,000 / month
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a. To lead, develop and sustain the company QMS in line with the required industry standards (including ISO 9001, ISO 13485), accreditation requirements and business requirements across the organization through existing and new documented procedure.

b. To ensure the company QMS is promoted continuously preserve, maintained and improve. Setting up and maintaining controls and documentation procedures. (including of write up of documents/policy/procedures) and ensuring distribution is control.

c. To be the guardian for the company quality system documentation, to ensure no unauthorized use of the company documents.

d. Responsible to update company product technical documentation, to ensure no unauthorized use of the company documents.

e, To assist management representative, maintain company quality manual and other company manual (i.e environmental, security and etc)

f. To manage the audit program to ensure that all non-conformities raised from certification bodies, customers or against supplier during audits are effectively corrected and independently verified.

g. To ensure the company sets objectives are achieved, continuously monitored and improved.

h. Ensuring compliance with in-house and international standards and legislation

i. Directly supervises quality management system team.

j. To assist marketing department and regulatory affairs section on technical information and technical writes up require by customer.

k. To liaise with Factory Manager, Marketing Manager and Chief Operating Officer in establishing product specifications.

l. Responsible to lead the team when compliance issues arise or are identified, related to certification and new or revised regulatory requirement.

m. Responsible to prepare the Weekly Quality System Management Report.

n. Responsible in handling customer audit, external party audit and regulatory audit.

o. Coordinate regular internal/external process audits of the QMS (i.e process audit, documentation audit, 5S audit).

p. To perform and write the report evaluation on the supplier audits for the company's vendor assessment and management review reporting.

q. To ensure safety working environment in the section area by conducting regular inspection to recognized, evaluate and control hazard and complying with all internal and external environmental, health and safety rules and regulation.

Job Requirement

  • At least (4) four years of working experience in the related field is required for this position.
  • Preferably Senior Executive specializing in QMS or equivalent. Those who had been working in a medical device application is an added advantage.
  • Knowledge in MDA, WRAP, CTPAT and COC and have experience as internal auditor for ISO 9001, ISO 13465 and ISO 14001.
  • Must be good oral and written communication in English and Bahasa Malaysia.
  • Must have interpersonal skills and be focused on achieving key objectives in your work area.
  • Must be a team player who can also work independently when required.

Job Type: Full-time

Pay: RM3,500.00 - RM6,000.00 per month

Benefits:

  • Additional leave
  • Free parking
  • Health insurance
  • Maternity leave
  • Opportunities for promotion

Schedule:

  • Monday to Friday