Biocompatibility Specialist

Kelly Science, Engineering, Technology & Telecom

Raynham (MA)

On-site

USD 110,000 - 117,000

Full time

14 days+

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Job summary

A leading staffing and recruiting firm in Raynham, MA, is seeking a Biocompatibility Specialist to conduct biological safety evaluations of medical device materials. The role involves collaborating with engineers and toxicologists to ensure compliance with international standards and regulatory requirements. Candidates should possess a Bachelor’s or Master’s degree in a scientific discipline, with 2–5 years of relevant experience. The position supports hands-on exposure to ISO standards and involves extensive documentation and cross-disciplinary teamwork. Full-time employment with competitive compensation will be provided.

Qualifications

Minimum 2–5 years of experience in biocompatibility evaluation within regulated environments.
Understanding of medical device manufacturing processes preferred.
PhD preferred with at least 1 year of industrial experience.

Responsibilities

Plan and execute biological safety evaluations according to ISO 10993.
Review product documentation related to materials and manufacturing.
Compile and write Biocompatibility Test Plans and Test Reports.

Skills

Toxicology knowledge

Biological safety assessment

Written and verbal communication in English

Collaborative work

Education

Bachelor’s or Master’s degree in relevant field

Job description

Kelly Science, Engineering, Technology & Telecom provided pay range

This range is provided by Kelly Science, Engineering, Technology & Telecom. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$110,000.00/yr - $117,000.00/yr

Biocompatibility Specialist

The Biocompatibility Specialist is responsible for planning, coordinating, and executing biological safety evaluations of medical device materials and products. Working within a cross‑functional team, the role ensures that devices meet international standards and regulatory requirements for biocompatibility, supporting both product development and regulatory submissions.

This position offers hands‑on exposure to ISO 10993 standards, laboratory testing, and risk assessment processes, with opportunities to collaborate with toxicologists, engineers, and regulatory teams.

Key Responsibilities

Plan and execute biological safety evaluations according to ISO 10993 and applicable regulatory requirements.
Review product documentation related to materials, manufacturing processes, sterilization, packaging, and cleaning validation.
Identify potential gaps in ISO 10993‑1 compliance and support testing requirements.
Design, coordinate, and interpret laboratory investigations for biocompatibility testing.
Ensure all testing complies with ISO, FDA, GLP, and other relevant regulatory standards.
Compile, write, review, and approve Biocompatibility Test Plans, Test Reports, and Biological Safety Risk Assessments.
Support regulatory submissions and preparation of technical files.
Contribute to problem‑solving for complex biocompatibility or toxicological issues.
Partner with R&D, Regulatory Affairs, Quality Engineering, Manufacturing, Packaging, and Project Teams to achieve project goals.
Collaborate with internal scientists, toxicologists, and external laboratory consultants.
Work cooperatively across disciplines to meet deadlines and ensure compliance.
Drive problem resolution efficiently using analytical and problem‑solving skills.
Demonstrate flexibility, adaptability, and commitment to continuous improvement.
Maintain high standards of documentation, communication, and ethical conduct.

Required Qualifications & Experience

Bachelor’s or Master’s degree in biology, chemistry, toxicology, microbiology, biomedical engineering, or a related scientific discipline.
Minimum 2–5 years of industrial experience in biocompatibility evaluation within medical device, pharmaceutical, or regulated consumer product environments.
Knowledge of toxicology, biological safety assessment, and coordination/interpretation of biocompatibility studies.
Understanding of medical device manufacturing processes is preferred.
Strong written and verbal communication skills in English.
Ability to work collaboratively in a dynamic, multi‑functional environment.

Preferred Experience

PhD with at least 1 year of industrial experience in biocompatibility evaluation.
Familiarity with regulatory submissions and technical file preparation.
Exposure to ISO 10993 testing coordination and laboratory management.
Analytical thinking and problem‑solving skills.
Attention to detail and quality focus.
Proactive, self‑directed, and resilient under pressure.
Ethical, transparent, and committed to teamwork.

Seniority level