Regulatory Affairs Specialist, IVD Diagnostics

INBIOS INTERNATIONAL INC; Washington (District of Columbia); On-site; USD 92,000 - 125,000; Full time

Benefits offered by this job

Medical, dental, vision, life &dis

401(k) + Roth IRA + FSA options

2 weeks paid vacation + 11 paid public

Competitive pay and growth

Supportive, team-oriented culture

Job summary

InBios International Inc in Seattle, WA seeks a Regulatory Affairs Associate II to support regulatory submissions and lifecycle management of IVD products. The role involves coordinating with cross-functional teams, preparing EUAs, 510(k)s, and international registrations, and maintaining design history files in a fast-paced environment.

Applicants should have 5+ years in FDA-regulated IVD regulatory affairs, strong communication, and a solid grasp of US and international regulations.

Qualifications

• Minimum 5 years regulatory affairs within FDA-regulated IVD manufacturing
• Experience preparing regulatory submissions (EUA, 510(k), De Novo, PMA)
• Strong knowledge of US and international IVD regulations
• Excellent written and verbal communication
• Detail oriented with strong project management

Responsibilities

• Represent or lead Regulatory Affairs in project teams throughout product life cycle.
• Write/review protocols for analytical studies in support of regulatory submissions.
• Assist in the preparation and submission of EUAs, pre-submissions, 510(k)s for class II products.
• Support international registrations, create and maintain technical files, and prepare product dossiers.
• Prepare and maintain Design History Files.
• Lead Risk Management effort.
• Prepare and review labeling and marketing materials to ensure regulatory compliance.
• Help set the regulatory strategy for new product development.
• Keep abreast with the latest regulatory requirements and trends.
• Communicate with the FDA and other regulatory bodies concerning product submissions.

Skills

Regulatory affairs

FDA regulations

510(k) submissions

EUA submissions

Regulatory strategy

Risk management

Labeling compliance

Cross-functional collaboration

Statistics

Project management

Compliance risk

Education

Bachelor's or Master's in Life Sciences

Regulatory affairs certification

Tools

MS Office

SharePoint

Statistical packages

Online research

Job description

InBios International Inc in Seattle, WA seeks a Regulatory Affairs Associate II to support regulatory submissions and lifecycle management of IVD products. The role involves coordinating with cross-functional teams, preparing EUAs, 510(k)s, and international registrations, and maintaining design history files in a fast-paced environment.

Applicants should have 5+ years in FDA-regulated IVD regulatory affairs, strong communication, and a solid grasp of US and international regulations.