Brecksville, Ohio, 44141
Job description
Job Summary
The Regulatory Affairs Specialist plays a crucial role in ensuring that products comply with relevant regulations and standards. This position involves collaborating with various departments to facilitate the submission of regulatory documents and support the approval process for new products.
Responsibilities
- Develop and submit regulatory documents for new product applications and modifications.
- Maintain up-to-date knowledge of regulatory requirements and guidelines.
- Interface with regulatory agencies to ensure compliance and address inquiries.
- Assist in the preparation of product labeling and promotional materials to ensure conformity with regulations.
- Conduct internal audits to ensure compliance with quality management systems.
Qualifications
- Bachelor’s degree in a relevant scientific field or equivalent experience.
- Experience in regulatory affairs within the healthcare or pharmaceutical industry.
- Strong understanding of FDA regulations and submission processes.
- Excellent communication and organizational skills.
- Ability to work effectively in a team and manage multiple projects.
Location
City, State Zip
Work Arrangement
Remote
Applied Medical Technology Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
