Full-Time

Regulatory Affairs Manager

Posted on 5/6/2024

BioAgilytix

BioAgilytix

501-1,000 employees

Provides bioanalytical services for pharmaceuticals

Food & Agriculture
Data & Analytics
Biotechnology

Senior

Durham, NC, USA

Required Skills
Communications
Requirements
  • Bachelor's degree in biology, chemistry, or related discipline
  • Minimum of 8 years experience in pharmaceutical, CRO/CMO, or similar organization
  • Strong knowledge of IDE/IVDR requirements
  • Understanding of cGMP for Medical Devices, ISO 13485, FDA, and (New) EU Medical Device requirements
  • Experience with CE Mark product certifications
  • Project coordination and management skills
  • Ability to work independently in a fast-paced environment
  • Excellent oral and written communication skills
  • Strong interpersonal skills
  • Proficiency in Microsoft Office
  • Attention to detail and organizational skills
Responsibilities
  • Provide guidance to product core teams for regulatory submissions
  • Review and interpret FDA/international regulations
  • Prepare pre-market submission reports and technical files
  • Coordinate regulatory issue resolution
  • Advise on compliance strategies
  • Assist in updating internal policies and procedures
  • Support regulatory compliance to ISO, FDA, and other regulatory requirements
  • Conduct trainings and communicate materials for working in a regulated environment

BioAgilytix specializes in bioanalytical services for pharmaceutical and biotech partners, offering assay development, validation, and sample analysis using technologies such as qPCR, flow cytometry, immunoassays, SPR biomarker interactions, and liquid handling automation. With laboratory locations across the US, Australia, and Germany, BioAgilytix supports drug development and release testing across various industries and disease states, providing high-quality science, data integrity, and regulatory compliance throughout clinical development phases.

Company Stage

Series A

Total Funding

$30.2M

Headquarters

Durham, North Carolina

Founded

2008

Growth & Insights
Headcount

6 month growth

-1%

1 year growth

0%

2 year growth

10%