Medline
Principal Toxicologist - remote - (Job Number: QUA0101RI)
This job is now closed
Job Description
- Req#: 721773
Employer Industry: Medical Device and Pharmaceutical
Why Consider this Job Opportunity:
- Competitive salary range of $130,000 - $229,320 annually
- Bonus eligibility
- Opportunity for career growth and development within the organization
- Remote work opportunity with periodic travel to corporate headquarters
- Chance to contribute to product development and market launch
- Work in compliance with ISO standards and regulatory agencies
What to Expect (Job Responsibilities):
- Provide technical expertise and support to internal business partners and product development teams
- Conduct toxicological risk assessments for medical device, OTC, and cosmetic products
- Prepare biological evaluation plans and reports for regulatory submissions
- Stay current with ISO standards and regulatory agency guidance documents
- Develop regulatory strategies to support biological evaluation plans
- Coordinate biocompatibility and safety testing
- Represent the employer on technical committees and contribute to the development of test standards
What is Required (Qualifications):
- Bachelor's degree in Chemistry, Biochemistry, Biology, Toxicology, or related science field
- 10 years of industrial experience in Medical Device, Pharmaceutical, or Biotechnology with expertise in biocompatibility and toxicology
- Knowledge of FDA requirements and experience with FDA interactions
- Working knowledge of FDA, EU MDR, ISO 10993, and ISO 14971
How to Stand Out (Preferred Qualifications):
- Active Diplomate of the American Board of Toxicology (DABT) certification
- Experience and knowledge of ISO 18562 and chemical characterization risk assessment
- Knowledge of pharmaceutical-related field
- Experience with quality audits by external regulatory bodies
- Strong communication, interpersonal, and problem-solving skills
#MedicalDevice #Pharmaceutical #Toxicology #RegulatoryCompliance #Biocompatibility
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We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.About the company
Medline Industries, LP, is a private American healthcare company based in Northfield, Illinois.
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