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Biocompatibility Specialist Jobs (NOW HIRING)

Arthrex

Biocompatibility Specialist II

Naples, FL · On-site

Biocompatibility Specialist II Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a ...

ARTHREX

Biocompatibility Specialist II

Naples, FL · On-site

Biocompatibility Specialist II Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a ...

LeMaitre

Sr. Specialist, Regulatory Affairs

Burlington, MA · On-site

$110K - $150K/yr

Mentor junior RA Specialists. * Other responsibilities assigned by the management. Pay range $110 ... Familiar with biocompatibility, sterilization, packaging, shelf life and associated ISO standards.

Boston Scientific

$89.20 - $169.50/hr

As a Senior Regulatory Affairs Specialist, you will provide Regulatory Affairs support for product ... or Biocompatibility. * Demonstrated experience with regulatory requirements for implantable or ...

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Biocompatibility Specialist information

What is the difference between Biocompatibility Specialist vs Material Scientist?

AspectBiocompatibility SpecialistMaterial Scientist
CredentialsTypically requires a degree in biology, biomedical engineering, or related fields; certifications in biocompatibility testing are commonUsually holds a degree in materials science, chemistry, or engineering; advanced certifications may include materials testing or characterization
Work EnvironmentLaboratories, medical device companies, regulatory agenciesResearch labs, manufacturing facilities, industrial settings
Industry UsageMedical devices, implants, pharmaceuticalsManufacturing, product development, research in various industries

While both roles involve working with materials, a Biocompatibility Specialist focuses on testing and ensuring materials are safe for biological use, especially in medical applications. A Material Scientist develops and analyzes materials for various purposes, often in broader industrial contexts. Both roles require scientific expertise but differ in their specific focus and application areas.

What is a biocompatibility specialist?

A Biocompatibility Specialist is a professional who evaluates medical devices, materials, or products to ensure they are safe and compatible with living tissue. They conduct tests and assessments according to regulatory guidelines to determine if a product causes any adverse biological reactions. This role is crucial in the medical device industry to meet safety standards and obtain regulatory approvals. Biocompatibility Specialists often work closely with research, development, and regulatory teams to ensure products are both effective and safe for human use.

What are some common challenges biocompatibility specialists face when evaluating new medical devices?

Biocompatibility Specialists often encounter the challenge of interpreting complex biological data to ensure that new materials and devices are safe for human use. They must stay current with evolving international regulatory standards and carry out thorough risk assessments, sometimes with limited preclinical data. Collaboration with R&D, regulatory, and clinical teams is essential to gather all necessary information, and clear communication is key when unexpected test results require quick problem-solving and adjustments to testing strategies.

What are the key skills and qualifications needed to thrive as a biocompatibility specialist?

To thrive as a Biocompatibility Specialist, you need a strong background in biology, chemistry, or biomedical engineering, often supported by a relevant degree and knowledge of regulatory standards such as ISO 10993. Familiarity with laboratory testing methods, toxicological risk assessment, and compliance tools is typically required, with some roles preferring certifications like Certified Biological Safety Professional (CBSP). Strong analytical thinking, attention to detail, and effective communication are vital soft skills for interpreting data and collaborating across teams. These skills are essential for ensuring the safety and regulatory compliance of medical devices, which directly impacts patient health and product approval.
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Infographic showing various Biocompatibility Specialist job openings in the United States as of August 2026, with employment types broken down into 84% Full Time, 13% Part Time, and 3% Contract. Highlights an 79% Physical, 2% Hybrid, and 19% Remote job distribution.

Biocompatibility Specialist II

Arthrex

Naples, FL • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 3 hours ago

Arthrex rating

8.0

Company rating: 8.0 out of 10

Based on 76 frontline employees who took The Breakroom Quiz

134th of 537 rated manufacturers

Job description

Requisition ID: 66518 Title:Biocompatibility Specialist II
Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Biocompatibility Specialist II for our Global Headquarters in Naples, FL. The Biocomp Specialist II is responsible for maintaining Arthrex, Inc's biological safety projects in accordance with Quality Systems Requirements. The ideal candidate will have a BS in Chemistry, Biology, or Toxicology along with 2 years relevant experience. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
Essential Duties and Responsibilities:
  • Develop and manage internal programs, with a global perspective, on biological safety risk assessment, toxicological risk assessments, testing plans / strategies, test parameters and methods through understanding and implementation of analytical/chemical, in silico, in vitro, and in vivo testing methodologies in accordance with ISO 10993, FDA Guidance, and global regulatory requirement;
  • Participate in design review meetings as a key member of new product design teams to assess products for biocompatibility and related biological safety concerns, including documentation of biological safety assessments, test plans, and associated reports;
  • Actively represent Arthrex and the medical device industry through active involvement in international standards committees such as AAMI, ISO, and SOT;
  • Manage the appropriate maintenance, review, and gap analysis / impact assessment of external standards, regulatory requirements, and guidance's associated with biological safety;
  • Function as lead auditor and/or subject matter expert for quality management system audits of Arthrex's global laboratory service providers in accordance with applicable standards, e.g., ISO 13485, ISO/IEC 17025, and international regulatory directives;
  • Mentor teams, share experience, and provide best practices to biological safety/quality staff related to biological safety systems, corporate policy, and regulatory requirement;
  • Encourage and foster an environment based upon a foundation of continuous process improvement and industry benchmarking;
  • Support and lead Arthrex's business and expansion goals;
  • Must be able to travel domestically and internationally up to 10% of the time

Education and Experience:
  • Bachelor's Degree in Chemistry, Toxicology, Biology, or related science field required.
  • 2 years relevant experience required
  • Previous project management experience preferred.
  • DABT Certification Preferred.

Knowledge and Skill Requirements/Specialized Courses and/or Training:
Specialized training in manufacturing operations, system design and development, terminal sterilization methods, industrial statistics, and technical writing preferred. Experience in project management tools are highly desirable. Experience in working with Toxicological Risk Assessments, Medical Device Risk Management (Specifically ISO 14971), CAPA, Complaint Management, and Nonconformance Reporting preferred.
Machine, Tools, and/or Equipment Skills:
Proficiency in the use of Personal Computers and computer programs, particularly the Microsoft Office Suite; Excel, Word, PowerPoint (or equivalents if changed by the Company). Solidworks, Minitab, and SAP or corporate ERP systems experience desirable.
Reasoning Ability:
Ability to define problems, identify opportunities, collect data, analyze established facts, draw valid conclusions, and implement change. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Mathematical Skills
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
Language and Communication Skills:
Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.
Arthrex Benefits
  • Medical, Dental and Vision Insurance
  • Company-Provided Life Insurance
  • Voluntary Life Insurance
  • Flexible Spending Account (FSA)
  • Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
  • Matching 401(k) Retirement Plan
  • Annual Bonus
  • Wellness Incentive Program
  • Free Onsite Medical Clinics
  • Free Onsite Lunch
  • Tuition Reimbursement Program
  • Trip of a Lifetime
  • Paid Parental Leave
  • Paid Time Off
  • Volunteer PTO
  • Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.
Making People Better at Arthrex
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Job Details
Date: Aug 6, 2026
Requisition ID: 66518
Salary Range:
Job title: Biocompatibility Specialist II
Arthrex
Location:

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