Manager – Regulatory Affairs
Caris Life Sciences
full-time
Posted on:
Location Type: Remote
Location: United States
Visit company websiteExplore more
Salary
💰 $124,000 - $152,000 per year
About the role
- Lead as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies.
- Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change.
- Prepare documents necessary for new product market clearance, approval, and continuance during product life cycle management.
- Lead pharmaceutical partner interactions on new and sustaining projects including regulatory strategy and pre-submissions.
Requirements
- Bachelor’s degree in a science-related area of study.
- 8+ years hands-on submission experience including the development and execution of regulatory strategies for medical device and/or IVD regulated products.
- Strong understanding of product development processes, design controls.
- Proficient with MS Office computer programs, including Word, Power Point, Excel, Visio, Outlook and Project.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategiessubmission experienceproduct development processesdesign controls
Soft Skills
leadershipcommunication