Global Leader in Rehabilitation and Performance Solutions
Our client is a recognized global provider of rehabilitation, recovery, and performance products distributed in over 100 countries. Their portfolio includes trusted brands used by healthcare professionals, clinics, athletes, and wellness consumers worldwide. With decades of industry leadership and a strong compliance culture, they continue expanding across regulated global markets. Joining their team means contributing to products that improve quality of life while operating at world-class regulatory and quality standards.
Job Description
As a Global Regulatory Specialist, you support global registrations, renewals, and submissions for medical devices, OTC drugs, and cosmetic products. You review labeling claims, maintain technical documentation, collaborate with international regulatory partners, and ensure timely, compliant market clearances across global regions.
Your work directly impacts global expansion, audit readiness, and patient safety. With Emapta, you gain structured growth, exposure to international regulatory bodies, and a top 1% professional experience built for high-performing regulatory specialists.
Job Overview
Employment type: Full time
Shift: Night shift, Weekends Off
Work setup: Hybrid, Megatower, Ortigas
Exciting Perks Await!
- Day 1 HMO coverage with free dependent
- Competitive Salary Package
- Night differential pay to maximize your earnings
- Hybrid work arrangement
- Prime office location in Ortigas (Easy access to MRT stations, restaurants, and banks)
- Day shift schedule
- 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)
- 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
- Bachelor's degree in Engineering, Pharmaceutical, Life Sciences, or other related technical field
- 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
Preferred Qualifications
- ASQ or other regulatory certification
- Ability to self-motivate and drive results
- Experience interacting with EU, FDA, and other international regulatory bodies (including Health Canada)
- Project management experience
- Professional regulatory affiliations such as RAPS
Your Daily Tasks
- Assist with maintaining global registrations and listings for establishments, medical devices, 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 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!
Be part of a workplace that values excellence, collaboration, and growth. Recognized as one of HR Asia's Best Companies to Work For in Asia 2025, Emapta stands proudly alongside industry leaders, offering stability and exciting global career opportunities. Work with international clients while enjoying competitive compensation and a culture built on innovation and support. Grow professionally and personally in an inclusive environment designed to help you thrive.
Apply now and be part of the #EmaptaEra!
