Regulatory Affairs Specialist jobs in Lexington, KY

Company Description

BioPathogenix specializes in molecular diagnostics for infectious disease testing. We offer a range of products, including multiplex qPCR reagents, attenuated pathogen quality control, and alternate proficiency testing. Our focus is on providing accurate and reliable testing solutions to healthcare professionals.

Role Description

This is a full-time on-site role for a Regulatory Affairs Specialist in the Lexington–Fayette metropolitan area, KY. BioPathogenix seeks a Regulatory Affairs Specialist with Medical device submission experience with the FDA and EU. The Regulatory Affairs Specialist will manage regulatory documentation, ensure regulatory compliance, understand and implement regulatory requirements, and prepare regulatory submissions.

The ideal candidate will:

• Be passionate about Regulatory Affairs medical devices for Diagnostics Use and knowledge about Laboratory Developed tests.
• Experience with ISO 13485 is a must.
• Author and maintain technical files that are compliant with ISO 13485.
• Author and submit applications 510(k), PMA Application, and Technical Documentation.
• Subject Matter Expert to represent Regulations during internal and external audits by regulatory agencies.
• Participate in cross-functional teams for projects as assigned.
• Review protocols and reports for scientific validity and compliance with regulatory standards and provide scientific judgment to guide cross-functional teams.
• Perform Regulatory Assessments for design, manufacturing, and labeling changes to ensure compliance with regulations and standards where the product is registered.
• Research requirements and set priorities while maintaining project schedules.
• Provide guidance and oversight to team members related to regulatory compliance.
• Reviewing marketing literature for compliance with applicable regulations and company policies and procedures.
• Execute additional responsibilities as defined by management.

Qualifications

• Regulatory Documentation, Regulatory Compliance, and Regulatory Requirements
• Minimum of 4 years of regulatory affairs experience in the medical device industry with a track record of successful submissions.
• Experience with ISO 13485
• Excellent attention to detail and organizational skills
• Strong written and verbal communication skills
• Knowledge of FDA regulations and guidelines
• Bachelor's degree in a related field, such as Biology or Chemistry. Advanced degree preferred.

Job Type: Full-time

Pay: From $75,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Experience level:

• 4 years

Schedule:

• Day shift
• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• Regulatory Affairs: 4 years (Preferred)
• ISO 13485: 1 year (Preferred)

Work Location: Hybrid remote in Nicholasville, KY 40356