Regulatory Affairs Specialist

EG Healthcare Incorporation; Makati; Sur place; PHP 446 400 - 781 200; Plein temps

Avantages offerts par ce poste

Holiday Gifts

Employee Recognition

Résumé du poste

EG Healthcare Incorporation in Makati is seeking a Regulatory Affairs professional with 1-3 years of experience to coordinate submissions and ensure compliance across product development and manufacturing. You will prepare 510(k), PMA, NDA submissions, monitor regulatory changes, and work with cross-functional teams to align regulatory strategy.

This full-time, on-site role requires strong attention to detail, excellent communication, and the ability to prioritize tasks in a fast-paced

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 1–3 years of experience in regulatory affairs or related field.
• Strong knowledge of FDA regulations and processes.
• Excellent attention to detail and analytical skills.
• Strong communication and interpersonal skills.
• Ability to work independently and prioritize tasks.

Responsabilités

• Coordinate and manage regulatory submissions to the FDA and other regulatory agencies.
• Ensure compliance with regulatory requirements and standards throughout product development and manufacturing.
• Assist in the preparation of regulatory documentation and submissions including 510(k), PMA, NDA, etc.
• Monitor and analyze regulatory changes that could impact the organization.
• Collaborate with cross-functional teams to ensure alignment on regulatory strategy and requirements.

Connaissances

FDA regulatory knowledge

Attention to detail

Communication skills

Formation

Bachelor's degree in Life Sciences

Description du poste

On-site - Makati 1-3 Yrs Exp Bachelor Full-time

Job Description

Employee Recognition and Rewards

Holiday Gifts

Government Mandated Benefits

Description

• Coordinate and manage regulatory submissions to the FDA and other regulatory agencies.
• Ensure compliance with regulatory requirements and standards throughout product development and manufacturing.
• Assist in the preparation of regulatory documentation and submissions including 510(k), PMA, NDA, etc.
• Monitor and analyze regulatory changes that could impact the organization.
• Collaborate with cross-functional teams to ensure alignment on regulatory strategy and requirements.

Requirements

• Educational Qualifications: Bachelor's degree in Life Sciences or a related field.
• Experience Level: 1-3 years of experience in regulatory affairs or related field.
• Skills and Competencies: Strong understanding of FDA regulations and processes.
• Skills and Competencies: Excellent attention to detail and analytical skills.
• Qualities and Traits: Strong communication and interpersonal skills.
• Responsibilities and Duties: Ability to work independently and prioritize tasks effectively.