Ensure Zero-Defect Importation in Highly Regulated Markets
Our client operates within the highly regulated medical device industry, delivering essential healthcare products across global markets. They are recognized for their strict adherence to international regulatory standards, ensuring safe and compliant distribution of Class I and II medical devices. With a strong commitment to quality systems and regulatory excellence, they continue to expand their global footprint while maintaining audit-ready operations and seamless cross-border logistics.
About the Role
As a Regulatory Quality Associate - Importer, you will operate at the critical intersection of global trade and medical device compliance, ensuring that life-impacting products meet the highest regulatory standards before reaching the market. This role influences the reliability of international supply chains, strengthens regulatory governance, and offers a long-term global career with Emapta-crafted for professionals who deliver precision, accountability, and impact at scale.
Job Overview
Employment Type: Full time
Shift: Mid Shift, Weekends Off
Work Setup: Hybrid - Megatower, Ortigas
What's in It for You
- Day 1 HMO coverage with free dependent
- Competitive Salary Package
- Hybrid work arrangement
- Prime office location in Ortigas (Easy access to MRT stations, restaurants, and banks)
- Fixed weekends off
- Salary Advance Program through our banking partner (Eligibility and approval subject to bank assessment. Available to account holders with minimum of 6 months company tenure.)
- Unlimited upskilling through Emapta Academy courses (Want to know more Visit: https://emapta.com/training-calendar/)
- Free 24/7 access to our office gyms (Ortigas and Makati) with a free physical fitness trainer!
- Exclusive Emapta Lifestyle perks (hotel and restaurant discounts, and more!)
- Unlimited opportunities for employee referral incentives across the organization
- Standard government and Emapta benefits
- Total of 20 annual leaves to be used on your own discretion (including 5 credits convertible to cash)
- Fun engagement activities for employees
- Mentorship and exposure to global leaders and teams
- Career growth opportunities
- Diverse and supportive work environment
Qualifications
- Bachelor's degree in Pharmacy, Life Sciences, or a logistics-related technical field
- 3 to 7 years of experience in Regulatory Affairs with focus on importation governance
- Proven experience reviewing importation documents such as commercial invoices, bills of lading, packing lists, and certificates of origin
- Working knowledge of EU MDR Article 13 (Importer Obligations) and Philippine FDA importation requirements (LTO, CPR, CMDN)
- Proficiency in SAP, TrackWise, or Veeva
- Advanced Microsoft Excel skills for data reconciliation
- Strong analytical skills with keen attention to detail
- Eager to learn, adaptable, proactive, and mature in supporting business goals
- Excellent verbal and written communication skills
Responsibilities
- Import Documentation Review: Perform 100% verification of shipping and quality documents to ensure zero discrepancies before customs release
- Compliance Oversight: Execute importer obligations under EU MDR Article 13 and ensure all devices are correctly labeled and registered before market entry
- Agency Liaison: Coordinate directly with the FDA, Bureau of Customs (BOC), and PDEA to facilitate seamless product entry
- Post-Market Surveillance: Triage customer complaints and adverse events (AE) for imported products and ensure timely escalation to Global Quality
- Variation Management: Lead submission of PCPR variations, including shelf-life extensions and addition of alternative foreign manufacturers
KPIs - Importer Quality
- Zero Shipment Holds: Eliminate delays attributable to missing or incorrect importation or regulatory documentation
- 100% MDR Compliance: Achieve full adherence to Article 13 requirements with zero audit findings
- Audit Readiness: Ensure 100% availability of complete Golden Folders for every imported batch
Welcome to Emapta Philippines!
Join a team that values camaraderie, excellence, and growth. Recognized as one of HR Asia's Best Companies to Work For in Asia 2025 and a finalist in 2026 Inspiring Workplaces Awards Asia, Emapta stands proudly alongside industry giants, offering stability and exciting career opportunities. Your career flourishes here with competitive compensation, international clients, and a work culture focused on collaboration and innovation. Work with global clients across industries, supported by a stable foundation and like-minded professionals passionate about making an impact. We empower your success with opportunities for personal and professional development in an inclusive environment.
Apply now and be part of the #EmaptaEra!
