Regulatory Affairs Associate Job at Adaptive Biotechnologies, Remote

  • Adaptive Biotechnologies
  • Remote

Job Description

Regulatory Affairs Associate supporting submission and compliance activities for in vitro diagnostic devices across US and international markets. The role involves managing regulatory documentation, coordinating FDA submissions, and maintaining compliance files while assisting with process improvements.

Responsibilities

  • Assist in writing and implementing process improvements for regulatory functions
  • Maintain and file regulatory documents per standard operating procedures
  • Compile and format materials for submissions and technical file documentation
  • Coordinate submissions per FDA and global health authority requirements
  • Communicate regulatory impacts and updates to cross-functional teams

Requirements

  • Bachelor's degree
  • 2+ years regulatory affairs experience in diagnostics or pharmaceutical industry
  • Knowledge of FDA guidelines and quality systems regulations
  • Experience with IVDs, molecular diagnostics, or CLIA laboratories preferred

Compensation: $38.56 - $57.88 hourly; equity grant and bonus eligible

Job Tags

Hourly pay

Similar Jobs

R&H Construction Co.

Future Opportunities Job at R&H Construction Co.

 ...qualifications or interest level.Compensation & BenefitsCompetitive Salary and Benefit Package401k and Company MatchMedical/Dental/Vision InsuranceDisability & Life InsuranceEducation & Training ClassesGenerous Paid Time Off9 Paid HolidaysCompany Social &... 

Rose Valley Management

Service Technician Job at Rose Valley Management

 ...apartment repairs (routine and preventative) in the scope of plumbing, HVAC, electrical, carpentry, wall repairs, painting, plumbing and appliances. Further oversight of the buildings curb appeal though building exterior inspections, cleaning, and grounds maintenance is... 

MOBILITY SOLUTIONS, INC.

Medical Billing Technician DME Job at MOBILITY SOLUTIONS, INC.

 ...include billing insurance companies for DME equipment Primarily wheelchairs. and working with...  ...and denials. Also checking data and preparing claims either electronicly or paper. Need...  ...also 401K. Hours are M-F 8 a.m. to 5 p.m. Medical Billing Tech. Billing in any medical... 

Apollo After School

After School Educator Job at Apollo After School

 ...Immediate start! Teacher jobs available in your area. Do you have childcare experience? Do you want to continue learning about education? Do you love working with children? Apollo After School is looking for you! Compensation: Starting at$21 per hour(... 

Robin Judson Partners, Llc.

164. Special Situations Senior Analyst, Credit Investment Desk Job at Robin Judson Partners, Llc.

Our client, an active credit investment desk in NYC, wants to add Senior Analysts to their...  ...and investment grade) and occasionally, equity. Our client has a robust and unique risk...  ...investment ideas across the public and private markets. This is a generalist role that...