Operational Compliance Specialist

Regulatory Compliance Officer – Manila

Company: Aljeron Medical Enterprises, Inc. (AMEI). Location: Metro Manila, Philippines. Job Type: Full-time, Permanent on-site.

Qualifications:

• Bachelor of Science in Pharmacy, Chemistry, or equivalent.
• Must have a valid PRC license.
• At least 1 year of work experience in regulatory industry, preferably in Medical Devices.
• Experience with ISO certification (ISO 9001:2015) is an advantage.
• Knowledge and skills in Regulatory Documentation, Compliance, and understanding of regulatory requirements for medical devices.

Responsibilities:

• Ensure company compliance with licenses, technical documents, and product registrations (e.g., LTO, CMDN/CMDR) and related amendments with FDA or regulatory agencies.
• Represent the company and liaise with regulatory authorities (e.g., FDA); ensure compliance with inspection requirements and provide accurate information as needed.
• Monitor and update distribution records for company products.
• Assist inventory in verifying deliveries against purchase orders and packing lists.
• Monitor ISO certification process and ensure compliance with international standards.
• Promote ethical standards and conduct seminars/training for compliance across the organization.
• Liaise with foreign principals for regulatory requirements and product registration status.
• Contribute to team goals and related outcomes as needed.

Company Description:

AMEI is a licensed servicer, importer, and distributor of surgical, diagnostic, laboratory, and radiological equipment and devices. Headquartered in Metro Manila, AMEI operates nationwide through its sales representatives, dealers, and biomedical engineers.

Benefits:

• Additional leave
• Health insurance
• Company events

Education/Experience/Licenses:

• Bachelor’s degree (required)
• Regulatory Compliance: 1 year (required)
• PRC License (required)

Regulatory Compliance Officer – Manila

Posting details may vary by posting source. Please reference the specific job listing for location and application instructions.

Regulatory Compliance Specialist – BGC, Taguig

Location: BGC, Taguig. Schedule: Night shift. Work setup: Hybrid.

Position overview:

Regulatory Compliance Specialist manages workload, supports regulatory quality initiatives, and interfaces with agencies and customers. Responsibilities include handling disclosure workload, maintaining compliance calendars, and multi-tasking across regulatory activities.

Responsibilities:

• Timely, accurate completion of customer deliverables
• Monitor regulatory workload and maintain compliance calendars
• Contribute to regulatory quality/process improvements
• Track customer data across software and forms
• Provide guidance to customers within defined processes
• Interact with agencies on disclosure requirements
• Maintain Regulatory Location Documents and support special projects

Qualifications:

• 2+ years in an EHS-related field preferred
• Knowledge of 40CFR and International Fire Code preferred
• Microsoft Office proficiency
• Strong communication, organization, and attention to detail
• Ability to work independently and collaboratively
• Willingness to adapt to business needs

Job Type: Full-time

Regulatory Compliance Associate – Philippines

Posted today

Job Description overview:

The Regulatory Affairs Associate supports regulatory submissions, interacts with government agencies (FDA Philippines), and ensures products meet regulatory approval processes for marketing in the Philippines.

Key duties:

• Prepare and submit regulatory documents (registrations, licenses, approvals)
• Prepare and review regulatory dossiers for product registrations, renewals, variations
• Monitor submission progress and deadlines
• Provide regulatory guidance to internal teams
• Ensure labeling and promotional materials comply with local regulations
• Interact with FDA Philippines, DOH, and other agencies; assist in audits/inspections
• Participate in post-market surveillance and recall procedures as needed
• Maintain organized records of submissions and approvals
• Stay updated on regulatory changes and industry trends

Qualifications:

• Bachelor’s degree (preferred)
• 1+ year experience in Regulatory Affairs Associate role (preferred)

Education/Experience note: Some postings include similar roles with varying details; refer to the specific listing for exact requirements.

Regulatory & Compliance Manager (example overview)

Location: Makati City, National Capital Region. Noted as a leadership role overseeing regulatory compliance programs across business units. Responsibilities include permits/licensing, regulatory submissions, audits, and government liaison. Qualifications typically include a degree in Law, Public Administration, Business Administration, or related field with 5–7 years of relevant experience; strong regulatory knowledge and leadership skills.

Note: This is a consolidated refinement of multiple postings; verify each listing for precise location, benefits, and requirements.

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