Medical Device Regulatory Documentation Specialist

Strengthen Global Health Access Through Precise Regulatory Documentation

In the medical device and wellness sector, documentation is far more than paperwork-it is the technical backbone that determines global market access, patient safety, and clinical trust. This opportunity places you at the center of worldwide compliance, supporting evidence-based submissions, managing critical regulatory files, and ensuring every product meets the stringent demands of FDA, EU MDR, Health Canada, and other global authorities. Here, your accuracy safeguards both clinical outcomes and international product readiness.

Job Description

Be part of our client's team as a Medical Device Regulatory Documentation Specialist, supporting global compliance, product registrations, and technical documentation for medical devices, OTC drugs, and wellness products. You will develop and maintain CERs, PMS reports, Technical Files, and labeling documentation while coordinating with international regulatory bodies to ensure alignment with FDA, EU MDR, Health Canada, UK MDR, and other global standards-enabling timely and safe market access worldwide.

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
• Double referral 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

• 3+ years preparing and defending regulatory submissions for medical devices or drug products, with strong preference for device experience.
• Strong understanding of global regulations including UK MDR 2002, EU MDR (2017/745), FDA Medical Device Law.
• Working knowledge of FDA 21 CFR Parts 201, 210, 211, 803, 806, 820, ISO 13485, and ISO 14971.
• Familiarity with global regulatory pathways and requirements for product classification, licensing, and registration.

Your Daily Tasks

• Assist with maintaining global registrations and listings for establishments, medical devices, over-the-counter (OTC) drugs, and cosmetics - annually for renewals and monthly for new product launches and global market expansions
• Perform reviews of existing and new product labeling claims to verify accuracy, substantiation, documentation, and compliance with applicable regulations
• Assist with the creation and maintenance of Declarations of Conformity and Technical Files on a quarterly basis
• Assist with the creation and maintenance of Technical File documents such as Post-Market Surveillance and Clinical Evaluation Reports
• Collaborate with EU and Swiss Authorized Representatives to report field actions and update technical files and declarations of conformity
• Provide support for determining medical device and drug classification in global markets
• Assist with global regulatory submission activities to secure market clearances, registrations, and licenses for medical devices and drug products
• Prepare and maintain global regulatory documents required to secure global licenses, registrations, and listings in a timely and cost-effective manner - including legalization and apostille of documents and obtaining FDA Certificates to Foreign Government (CFGs)
• Provide business support and expertise regarding regulatory requirements in global markets
• Assist with creation and maintenance of US Rx medical device and OTC drug licenses, and US law labels

Other Duties and Responsibilities:

• Support overall business goals through proactive regulatory intelligence and compliance strategy execution
• Collaborate cross-functionally to ensure regulatory documentation supports ongoing product quality and safety initiatives
• Maintain meticulous recordkeeping for audit readiness

Key Performance Indicators (KPIs):

• Maintain a 98% or higher accuracy rate in preparing and submitting regulatory documents, ensuring all filings meet applicable agency requirements and timelines
• Ensure 100% of required submissions (renewals, variations, registrations) are completed and submitted on or before internal and external deadlines
• Achieve zero major findings in internal or external regulatory audits through consistent adherence to documentation standards and proactive compliance monitoring

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