Pharmaceuticals & Medical Devices (Healthcare & Medical)
Bachelor's degree in a relevant scientific discipline, such as Biology, Medical Technology, Chemistry, or Pharmacy. At least 3 years of experience in regulatory affairs within the medical device or diagnostics industry, with specific experience in IVD preferred. Strong understanding of regulatory pathways, including product registration, variations Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams 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.
Your application will include the following questions:
What's your expected monthly basic salary?
How many years' experience do you have as a Regulatory Affairs Specialist?
Manpower Outsourcing Services, Inc. (MOSI), helps companies increase business flexibility, agility, cost effectiveness and competitive advantage. Manpower Philippines offers a wide range of expert services including contract and project recruitment, assessment and selection, training, HR services, business process outsourcing, and recruitment outsourcing.
Prime Manpower Resources Development, Inc. (Prime Manpower), an affiliate of Manpower, through its Permanent Staffing and Executive Search teams, provides total recruitment solutions to clients all over the country.
Manpower Outsourcing Services, Inc. (MOSI), helps companies increase business flexibility, agility, cost effectiveness and competitive advantage. Manpower Philippines offers a wide range of expert services including contract and project recruitment, assessment and selection, training, HR services, business process outsourcing, and recruitment outsourcing.
Prime Manpower Resources Development, Inc. (Prime Manpower), an affiliate of Manpower, through its Permanent Staffing and Executive Search teams, provides total recruitment solutions to clients all over the country.
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