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.
Qualifications:
- 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.
- 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.
Your application will include the following questions:
What's your expected monthly basic salary?
How many years' experience do you have as a Regulatory Specialist?
Knoll Ridges Consultancy is comprised of HR Professionals who have extensive background in the field of human resources and Senior Executives with diversified business experience.
In addition to this internal talent, Knoll Ridges Consultancy has developed strategic partnerships with other consulting firms and individuals to provide specialized services. For each project, we assemble an experienced team of consultants based on our client's unique business needs.
Our goal is to support companies and highly talented individuals in obtaining and improving employment, and to provide seamless, efficient services through our unique framework and methodologies.
STRATEGIC FORESIGHT
Knoll Ridges Consultancy will help bring the human resources department into alignment with its internal customers by ensuring that it is organized effectively by using benchmarks and best practices to ensure that the human capital and competency levels are appropriate for the services provided by your company.
WHO WE ARE
Knoll Ridges Consultancy is comprised of HR Professionals who have extensive background in the field of human resources and Senior Executives with diversified business experience.
In addition to this internal talent, Knoll Ridges Consultancy has developed strategic partnerships with other consulting firms and individuals to provide specialized services. For each project, we assemble an experienced team of consultants based on our client's unique business needs.
Our goal is to support companies and highly talented individuals in obtaining and improving employment, and to provide seamless, efficient services through our unique framework and methodologies.
STRATEGIC FORESIGHT
Knoll Ridges Consultancy will help bring the human resources department into alignment with its internal customers by ensuring that it is organized effectively by using benchmarks and best practices to ensure that the human capital and competency levels are appropriate for the services provided by your company.
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