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.