Regulatory Affairs Supervisor for Medical Device Company *Sto. Tomas City*

  • Prepares necessary documents for the approval of application and compliances with government authorities such as PDEA, FDA, BFAD ensuring timely submission.
  • Liaises with FDA and other agencies for product registration and other concerns.
  • Monitors validity of documents required by the business such as Licenses, Certifications, permits etc.
  • Maintains and renew certificates of product registration of existing products.
  • Files amendments/variations with FDA as may necessary.
  • Updates and disseminate information to all concerned department on the latest regulations and circular as need arises.
  • Performs necessary inspection in coordination with Team concerned on matter that may affect transaction with government agencies.
  • Creates and revises Standard Operating Procedures used by the company for operations under Regulatory.
  • Assists in the internal audits or 3rd party audits and closure of audit findings. 
  • Conducts training in relations to quality management systems.
  • Assists immediate superior in the continual review of internal processes and procedures.

Employer questions

Your application will include the following questions:
  • What's your expected monthly basic salary?
  • Which of the following types of qualifications do you have?
  • How many years' experience do you have as a Regulatory Affairs Supervisor?
  • How would you rate your English language skills?
  • How much notice are you required to give your current employer?
  • Are you willing to undergo a pre-employment medical check?
  • Are you available to work public holidays?

Company profile

Healthcare & Medical11-50 employees

ARKRAY Co. Ltd., Inc is a multinational Japanese company established in 2014, focuses on marketing, distribution and provides after sales service of clinical testing instruments and reagents used for diagnosis, treatment and medical examinations

ARKRAY focused on always providing new value to our customers and this is based on our founder’s drive for taking on challenges.

ARKRAY's vision is to positively influence society through sound, legitimate business practices.

Perks and benefits
Medical
Miscellaneous allowance
Education support
Dental

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