Medline Industries
R&D Specialist, Biocompatibility
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Job Description
- Req#: R2603189
Employer Industry: Medical Device and Pharmaceutical Development
Why consider this job opportunity:
- Salary up to $119,000 annually
- Eligible for bonuses and incentives
- Comprehensive benefits package including health insurance, life and disability coverage, and 401(k) contributions
- Opportunity for career growth within a global organization
- Engaging work environment focused on diversity and inclusion
- Potential for travel up to 10% for business purposes
What to Expect (Job Responsibilities):
- Plan and execute testing required to support product claims
- Author and review test protocols and reports
- Compile and review results for regulatory submissions, including 510k’s and ANDA/NDAs
- Ensure compliance of data collection activities with regulatory requirements
- Lead risk assessments and propose solutions for identified gaps
What is Required (Qualifications):
- Bachelor’s degree in Chemistry, Biology, or related science field
- At least 2 years of experience in a medical device or pharmaceutical field
- Knowledge of FDA requirements and experience with the 510k/ANDA/NDA approval processes
- Experience with risk assessment and root cause analysis
- Strong communication skills with the ability to work with cross-functional teams
How to Stand Out (Preferred Qualifications):
- Familiarity with CE technical files
- Experience in solving practical problems in varied situations
- Ability to work independently and demonstrate critical thinking skills
#MedicalDevices #Pharmaceuticals #CareerGrowth #CompetitiveSalary #DiversityAndInclusion
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