Regulatory Affairs Specialist

4 days ago


Cavite City, Calabarzon, Philippines RCX RECRUITMENT INC. Full time

Regulatory Affairs Specialist - Quality Job Summary:

We are looking for a Regulatory Affairs Specialist - Quality to join our team at RCX RECRUITMENT INC. The successful candidate will be responsible for ensuring the quality and regulatory compliance of our products and services.

Main Responsibilities:

  1. Providing FDA data and information to US Customs
  2. Working with FDA and US Customs to resolve shipments placed on hold
  3. Writing Health Risk Assessments for Nonconforming products, customer complaints, and MDRs
  4. Supporting Sales and Marketing to resolve FDA compliance questions or concerns
  5. Interpreting and applying regulatory guidelines to product importation, sales, and marketing processes
  6. Ensuring adherence to all applicable regulations and standards
  7. Managing the life cycle of regulatory submissions
  8. Providing guidance and support to other departments on regulatory matters

Requirements:

  1. Graduate of BS Pharmacy, Biology, Chemistry, or any life sciences-related courses
  2. Experience in regulatory affairs, quality assurance, or quality control
  3. Knowledge of US FDA regulations, guidelines, and processes
  4. Excellent communication and interpersonal skills
  5. Strong analytical and problem-solving skills
  6. Ability to work effectively with cross-functional teams


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