Regulatory Affairs Senior Specialist

1 week ago


Taguig, National Capital Region, Philippines Prime Manpower (A ManpowerGroup Licensee) Full time

Qualifications

Educational Background

Bachelor's degree in a relevant scientific discipline, such as Biology, Medical Technology, Chemistry, or Pharmacy.

Work experience required

At least 3 years of experience in regulatory affairs within the medical device or diagnostics industry, with specific experience in IVD preferred.

Technical / Functional Skills

In-depth knowledge of Philippine regulatory requirements for medical devices and IVD products.

Strong understanding of regulatory pathways, including product registration, variations.

Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.

Detail-oriented with strong organizational and project management skills.

Ability to work independently and prioritize tasks in a fast-paced environment.

Proficiency in Microsoft Office applications.

Behavioral Preferences / Soft Skills

*Other preferences (Age, gender, etc.)

Roles and Responsibilities

Job Description:

As a Regulatory Affairs Specialist for In Vitro Diagnostics, you will be responsible for overseeing all regulatory activities related to the registration, compliance, and ongoing maintenance of our IVD products in the Philippines. Your primary duties will include:

Collaborating with cross-functional teams to ensure regulatory requirements are met throughout the product lifecycle, from development to post-market surveillance.

Preparing and submitting regulatory submissions, including product registrations, variations, and renewals, to the Philippine Food and Drug Administration (FDA) in accordance with local regulations.

Providing regulatory guidance and support to internal stakeholders, including R&D, Quality Assurance, and Marketing teams, on matters related to product development, labeling, and promotional materials.

Monitoring changes in Philippine regulatory requirements and communicating potential impacts to the business.

Maintaining regulatory documentation and records in compliance with company procedures and regulatory standards.

Collaborating with cross-functional teams to ensure performance activities aligned with product launch timelines and regulatory requirement.


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