Brecksville, Ohio, 44141
Job description
The Regulatory Affairs Specialist plays a key role in the preparation and submission of regulatory filings to organizations like the FDA and Notified Bodies. This position involves ensuring adherence to international compliance standards and overseeing internal documentation that pertains to quality management systems. Applicants should possess a minimum of a two-year college degree, with a bachelor’s degree being advantageous, along with pertinent experience in a regulated industry. Familiarity with Microsoft Office is essential, and a solid understanding of FDA regulations, ISO 13485, and GMP guidelines is highly sought after.
STEMHUNTER is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, and gender expression), national origin, age, disability, genetic information, veteran status, or any other status protected by applicable federal, state, or local law. We comply with all applicable equal employment opportunity and affirmative action regulations.
