Regulatory Affairs Specialist: FDA Submissions & Compliance

EG Healthcare Incorporation; Makati; Vor Ort; PHP 446.400 - 781.200; Vollzeit

Benefits dieser Stelle

Holiday Gifts

Employee Recognition

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

FDA regulatory knowledge

Attention to detail

Communication skills

Ausbildung

Bachelor's degree in Life Sciences

Jobbeschreibung

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