Medical Device Regulatory Submissions Across US FDA and EU MDR
With decades of expertise and recognition in healthcare product innovation, our client provides rehabilitation and performance solutions that support recovery and physical well-being worldwide. Their products are distributed across more than 100 countries and trusted by professionals and consumers alike.
Their reputation is built on consistent quality, regulatory rigor, and a forward-looking approach to product development. This creates an environment where high-performing professionals can thrive while contributing to meaningful, life-improving solutions at scale.
Job Description
Driving global regulatory approvals across highly regulated markets, this Regulatory Associate role plays a critical part in ensuring healthcare products meet international compliance standards and reach patients worldwide. It directly supports expansion across the United States FDA (US FDA), European Union MDR (Medical Device Regulation), and APAC markets, influencing product availability, safety, and commercial success. With Emapta, it becomes a long-term global career designed for top 1% talent seeking high-impact work, global regulatory expertise, and continuous professional growth.
Job Overview
Employment type: Full time
Shift: Night shift, Weekends Off
Salary: Up to PHP150,000
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 a related technical field
- Minimum of 3+ years of hands-on experience preparing, reviewing, and defending regulatory submissions for medical devices and/or pharmaceutical products
- Proven experience supporting regulatory submissions across global markets, including APAC, United States FDA (US FDA), UK, and/or Canada (local-only regulatory experience is not sufficient)
- Strong working knowledge of US FDAregulatory requirements, EU MDRframework, and global product registration and lifecycle management
- Demonstrated experience working within ISO 13485 and ISO 14971 quality and risk management standards
- Hands-on experience interacting with global regulatory authorities (e.g., FDA, EU bodies, Health Canada)
- Ability to interpret and apply complex global regulatory requirements with high accuracy
- Strong project management skills with the ability to handle multiple submissions and timelines independently
Preferred Qualifications
- ASQ or other recognized regulatory certification
- Experience managing end-to-end regulatory projects across multiple regions
- Active membership in professional regulatory organizations (e.g., RAPS)
- Self-motivated with a strong ability to drive results and work independently in a global regulatory environment
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)
- Achieve ≥98% accuracy in regulatory document preparation and submissions, ensuring full compliance with agency requirements and timelines
- Ensure 100% on-time completion of all regulatory submissions, including renewals, variations, and registrations
- Maintain zero major audit findings 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 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!
