QA Assistant

Position Overview:

As a QA Assistant (Regulatory Compliance), you will play a key role in ensuring compliance with international regulatory standards for medical devices.

Work Schedule and Arrangement: 11:00PM-8:00AM, Onsite

Office Location: 8th floor Skyrise 4B Building, IT Park, Lahug, Cebu City, Cebu

Key Responsibilities:

Regulatory Compliance:

• Assist in maintaining compliance with international medical device regulations, including MDSAP 13485:2016, FDA, Health Canada, TGA Australia, and EU IVDR/IVDS
• Support the preparation, review, and submission of regulatory documents and reports
  
  

Documentation & Quality Assurance:

• Maintain quality management system (QMS) documentation to ensure regulatory alignment
• Assist in preparing Standard Operating Procedures (SOPs), work instructions, and other compliance-related documentation
  
  

Audits & Inspections:

• Support internal and external audits, ensuring readiness for regulatory inspections
• Assist in compiling necessary documentation for audits and responding to audit findings
• Ensure corrective and preventive actions (CAPA) are properly implemented and documented
  
  

Risk & Compliance Monitoring:

• Assist in identifying quality risks and implementing measures to mitigate compliance issues
• Coordinate with various departments to ensure continuous improvement in regulatory compliance efforts
  
  

Requirements:

• Bachelor’s degree
• At least 2 years of experience in regulatory compliance, quality assurance, or medical device industry
• Familiarity with global regulatory requirements, including MDSAP 13485:2016, FDA, Health Canada, TGA Australia, and EU IVDR/IVDS
• Knowledge of Quality Management Systems (QMS) and risk management principles
• Experience with documentation control and regulatory submissions is a plus
• Strong analytical skills with attention to detail
• Excellent organizational and time management skills
• Strong communication and collaboration abilities
  
  

Salary and monetary benefits (in PHP):

• Monthly salary of 23,000php - 39,000php (depending on experience)
• New hire bonus of 5,000php
• Monthly Risk allowance of 2,000php
  
  

Perks and other benefits:

• Paid Training Period
• All national Philippines and USA holidays are observed
• Paid time off—public holidays, vacation, and personal time off
• Robust and effective Government Benefits Administration
• Lactation breaks (for breastfeeding moms)
• Discounted optical services with our partner clinic
• Free lunch/dinner and unlimited coffee and ice cream daily (for onsite employees)
• Free Health insurance with one (1) free dependent
• Free Life insurance
• Free Accident insurance
• Relocation allowance for new hires (from outside Cebu)
• Company-sponsored outings
• Interest-based employee clubs (DOTA, Basketball, Dance, Music, Photography, Yoga)
  
  

Our Recruitment Process:

• Candidate Application Form
• General Assessment & Video Interview
• Follow up Phone Screening
• Technical Interview
• Reference Check
• Job Offer
• Training
  
  

Disclaimer for salary ranges: Salary ranges may not be applicable to all. Depending on the level of experience, educational background and potential for growth seen during interviews, offers may go higher or lower.

PRO TIP: prepare for that interview and impress the hiring managers!

For more information about our company, visit our website: www.medspecialized.com

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