Regulatory Associate | Onsite | Ortigas | Night Shift

Regulatory Associate – Night Shift (Onsite, Ortigas) The Construction Index Ltd is hiring a full‑time Regulatory Associate to support global compliance and product registration efforts for health, medical, and wellness products. The role is onsite at the Megatower office in Ortigas, Mandaluyong, National Capital Region, with a night shift schedule and weekends off. Job Overview Employment type: Full time Shift: Night Shift, Weekends Off Work setup: Onsite (Megatower, Ortigas) Key Responsibilities Maintain global registrations and listings for establishments, medical devices, over‑the‑counter drugs, and cosmetics – renewals annually and new launches monthly. Review product labeling claims to verify accuracy, substantiation, documentation, and regulatory compliance. Create and maintain Declarations of Conformity and Technical Files on a quarterly basis. Prepare Post‑Market Surveillance and Clinical Evaluation Reports. Collaborate with EU and Swiss Authorized Representatives to report field actions and update technical files. Support medical device and drug classification determinations in global markets. Assist with global regulatory submissions to secure market clearances, registrations, and licenses. Prepare and maintain global regulatory documents, including legalization, apostille, and FDA Certificates to Foreign Government (CFGs). Provide business support and expert guidance on regulatory requirements in worldwide markets. Assist with US Rx medical device and OTC drug license creation and maintenance, including compliance with U.S. law labeling. Support overall business goals through proactive regulatory intelligence and compliance strategy execution. Collaborate cross‑functionally to ensure documentation supports ongoing product quality and safety initiatives. Maintain meticulous recordkeeping for audit readiness. Provide administrative support and manage communications (including calls) for international clients in the EU, U.S., Canada, and other regions. Qualifications Bachelor's degree in Engineering, Pharmaceutical, Life Sciences, or related technical field. 3+ years of experience developing and defending complex regulatory submissions for medical devices and drugs. Proficiency in Microsoft Excel and data analysis tools. Highly analytical with a sharp eye for detail. Eager to learn, adaptable, takes initiative, and aligned with business goals. Excellent verbal and written communication skills. Preferred Qualifications ASQ or other regulatory certification. Self‑motivation and strong drive for results. Experience interacting with EU, FDA, Health Canada, and other international regulatory bodies. Project management experience. Professional regulatory affiliations such as RAPS. Key Performance Indicators (KPIs) Maintain 98%+ accuracy in preparing and submitting regulatory documents. Ensure 100% of required submissions (renewals, variations, registrations) are completed on or before deadlines. Achieve zero major findings in internal or external regulatory audits. Benefits & Perks Day 1 HMO coverage with free dependent. Competitive salary package. Night differential pay. Prime office location in Ortigas with easy MRT access. Fixed weekends off. Salary advance program available to eligible employees. Unlimited upskilling through Emapta Academy courses. Free 24/7 access to office gyms (Ortigas and Makati) with a free personal trainer. Exclusive lifestyle perks (hotel and restaurant discounts). Employee referral incentives across the organization. Standard government and company benefits. 20 annual leaves (including 5 cash‑convertible credits). Fun engagement activities. Mentorship and exposure to global leaders. Career growth opportunities. Diverse and supportive work environment. About Us We are a trusted leader in the health, wellness, and fitness industry, dedicated to improving lives through innovative medical and wellness products. Recognized as one of the Top 20 Dream Companies of Filipinos in 2024, we offer stability, global client exposure, and a collaborative culture that values innovation, inclusion, and personal growth. Apply now and join the #EmaptaEra #J-18808-Ljbffr