Ensure Global Market Access Through Medical Device Regulatory Documentation
Recognized globally for excellence in rehabilitation, recovery, and sports performance, this industry leader supports clinicians and patients in over 100 countries. Backed by award-winning brands trusted for clinical outcomes, their work enables safer, faster access to regulated medical and wellness products worldwide. Innovation, evidence-based solutions, and rigorous compliance define their success. Professionals here contribute to global health impact by ensuring products meet the highest regulatory standards-making this an ideal environment for specialists who value precision, responsibility, and meaningful outcomes.
Job Description
As a Global Regulatory Specialist, you will support global regulatory compliance and market access for medical devices, OTC drugs, and wellness products distributed internationally. This role focuses on the preparation, maintenance, and lifecycle management of regulatory documentation, including Technical Files, Clinical Evaluation Reports (CERs), Post-Market Surveillance (PMS), declarations of conformity, and product labeling.
You will collaborate with cross-functional teams and international regulatory partners to ensure documentation aligns with FDA, EU MDR, UK MDR, Health Canada, and other global requirements. Through precision, consistency, and audit-ready practices, you will help enable timely approvals, sustain compliance, and support safe product availability across global markets.
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
- Doublereferral 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
- 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
- Minimum of 3+ years of hands-on experience preparing and defending regulatory submissions for medical devices or pharmaceutical products across global markets (APAC, US, UK, and/or Canada)
- Strong familiarity with global regulatory pathways, including product classification, licensing, registration, and lifecycle maintenance
- Experience in APAC-based regulatory environments acceptable, provided there is direct pharmaceutical regulatory submission experience
- Working knowledge of quality and risk management standards, such as ISO 13485 and ISO 14971, and applicable regulatory requirements
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!
