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R&D Specialist, Biocompatibility
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Job Description
- Req#: R2603189
Employer Industry: Medical Devices and Pharmaceuticals
Why consider this job opportunity:
- Salary up to $119,000 annually
- Bonus and/or incentive eligible
- Comprehensive benefits package including health insurance, life and disability, and 401(k) contributions
- Opportunities for continuing education and training within a growing worldwide organization
- Work in a collaborative environment focused on diversity and inclusion
- Potential for career advancement in a dynamic field
What to Expect (Job Responsibilities):
- Plan and execute testing required to support product claims
- Author and review test protocols and reports
- Track and compile results for regulatory submissions, including 510k's and ANDA/NDAs
- Ensure compliance of data collection activities with applicable regulatory requirements
- Lead process improvement initiatives and represent the employer on technical committees
What is Required (Qualifications):
- Bachelor’s degree in Chemistry, Biology, or a related science field
- At least 2 years of experience in a medical device or pharmaceutical related field
- Knowledge of FDA requirements and experience with FDA interactions during approval processes
- Experience with risk assessment and root cause analysis
- Strong analytical and problem-solving skills, with the ability to work independently
How to Stand Out (Preferred Qualifications):
- Familiarity with CE technical files
- Experience communicating with cross-functional teams and various audiences
- Self-starter with excellent organizational skills
- Ability to solve practical problems in non-standardized situations
- Willingness to travel up to 10% for business purposes
#MedicalDevices #Pharmaceuticals #CareerGrowth #CompetitivePay #DiversityAndInclusion
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