Regulatory Affairs Specialist
Full-time
EG Healthcare Incorporation
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.
Vacancy posted a month ago
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