Senior Regulatory Affairs Associate
GeneDx
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $110,000 - $120,000 per year
Job Level
Senior
About the role
- Support the development and execution of regulatory strategies to ensure FDA authorization and global compliance for IVD and Software as a Medical Device (SaMD) products.
- Prepare and contribute to regulatory submissions, including FDA pre-submissions, 510(k), De Novo, and EU IVDR Technical Documentation.
- Collaborate with cross-functional teams to ensure regulatory requirements are integrated throughout the product lifecycle.
- Provide regulatory input during design and development activities, including risk management, change control, verification/validation, and labeling.
- Monitor and interpret evolving regulatory requirements and standards (e.g., ISO 13485, ISO 14971, IEC 62304, IEC 62366) and assess impact on product development and compliance.
- Support internal audits and regulatory inspections, including preparation of documentation and development of CAPAs related to regulatory findings.
- Deliver regulatory training and guidance to internal teams to support ongoing compliance and foster a strong quality and regulatory culture.
- Contribute to continuous improvement initiatives within the Regulatory Affairs function.
Requirements
- A bachelor’s or advanced degree in a relevant scientific or technical field (e.g., Biology, Chemistry, Engineering).
- Minimum of 5 years of experience in regulatory affairs within the medical device or IVD industry.
- Practical experience with FDA authorization and EU IVDR submissions, design controls, ISO 13485, ISO 14971, IEC 62304 and ISO 15189 regulations.
- Experience with Software as a Medical Device or medical devices containing software.
- Working experience in a clinical genetics laboratory is desired.
- Ability to manage multiple projects and priorities in a fast-paced environment.
Benefits
- Paid Time Off (PTO)
- Health, Dental, Vision and Life insurance
- 401k Retirement Savings Plan
- Employee Discounts
- Voluntary benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionsFDA pre-submissions510(k)De NovoEU IVDR Technical Documentationrisk managementchange controlverification/validationlabelingISO 13485
Soft skills
collaborationproject managementcommunicationtrainingcontinuous improvement