Regulatory Affairs Analyst | EUDAMED | Sign-on Bonus | Up to PHP150K

Ensure Market-Ready Health Products Through Precise Regulatory Execution

Medical devices reach clinicians only when every document meets global expectations. This environment values regulatory specialists who excel in interpreting standards, writing technical evidence, and managing submissions that cross borders. Your knowledge of MDR, FDA, ISO, and post-market requirements ensures every product aligns with clinical, safety, and reporting frameworks. Here, you help shape compliant access to rehabilitation and wellness solutions worldwide.

Job Description

As a Regulatory Affairs Analyst, you will support global product access by managing regulatory submissions, registrations, and technical documentation for medical devices, OTC drugs, and wellness products. You will review labeling claims, maintain compliance records, and coordinate with international agencies and representatives to ensure adherence to EU MDR, FDA, Health Canada, and other global regulatory frameworks. Your work strengthens documentation accuracy, supports product lifecycle compliance, and enables safe, timely market readiness across multiple regions.

Job Overview

Employment type: Full-time

Shift: Night Shift, Weekends Off

Salary: Up to PHP 150,000 + Sign-on bonus

Work setup: Onsite (Megatower, Ortigas)

Exciting Perks Await

• Day 1 HMO coverage with free dependent
• Competitive Salary Package with sign-on bonus
• Enhanced referral bonuses (DOUBLE INCENTIVE)
• Night differential pay to maximize your earnings
• 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 )
• 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

The Qualifications We Seek

• 5+ years of hands-on Regulatory Affairs experience specifically within Medical Devices or IVDs.
• Proven experience securing and maintaining product registrations in the EU, US (FDA), and/or Health Canada markets.
• Direct involvement in writing and maintaining Clinical Evaluation Reports (CERs) and Post-Market Surveillance Reports (PMS/PSURs).
• Strong understanding of EU MDR (2017/745) requirements and US FDA 510(k) documentation.
• Working experience with EUDAMED for device registration and maintenance.
• Bachelor's degree in Pharmaceutical Sciences, Life Sciences, or a related scientific field.
• Solid knowledge of ISO 13485, ISO 14971, and global regulatory frameworks for product registration and compliance.
• Understanding of FDA 21 CFR Parts 201, 210, 211, 803, 806, and 820.

Your Daily Tasks

• Support regulatory intelligence activities by monitoring global requirements and identifying updates that impact medical devices, OTC drugs, and wellness products.
• Collaborate with cross-functional teams to ensure regulatory documents align with product quality, safety, and market access initiatives.
• Maintain organized, audit-ready regulatory records and ensure all documentation meets global Quality System standards.
• Provide guidance on regulatory classifications, labeling requirements, and compliance strategies for new and existing products.
• Assist in coordinating global submissions, renewals, variations, and technical documentation updates to meet market timelines.
• Manage regulatory documentation needs such as legalization, apostille, Certificates to Foreign Government (CFGs), and related agency requirements.
• Contribute to continuous improvement efforts by identifying documentation gaps, process inefficiencies, and regulatory risks.

Key Performance Indicators (KPIs)

• 98%+ accuracy in preparing and submitting regulatory documentation across all global markets.
• 100% on-time submission for renewals, variations, registrations, and listing activities.
• Zero major findings during internal and external regulatory or quality audits.
• Full compliance with applicable regulatory frameworks, including EU MDR, FDA, Health Canada, and ISO standards.
• Consistent documentation readiness, ensuring Technical Files, CERs, PMS Reports, and Declarations of Conformity remain current and audit-compliant.

Welcome to Emapta Philippines

Join a team that values camaraderie, excellence, and growth. Recognized as one of the Top 20 Dream Companies of Filipinos in 2024, 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