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Biocompatibility Manager Jobs (NOW HIRING)

Ametek

Program Manager

Pierceton, IN

Summary: Responsible for managing all aspects of a new product launch for surgical instruments ... Knowledge of Design for Manufacturability (DFM) principles, biocompatibility requirements for ...

Medline

Principal Toxicologist

Northfield, IL · On-site +1

$152.88K - $229.32K/yr

... guide biocompatibility testing under GLP requirements. * Serve as a subject matter expert ... The ability to manage multiple projects simultaneously and work effectively in a matrixed ...

VERO BIOTECH INC

Project Manager

Atlanta, GA

Track testing progress for V&V, human factors and usability testing, biocompatibility, etc ... Serves as a promoter of the program management processes and initiatives and assists company ...

Medline

Principal Toxicologist

Northfield, IL

$152.88K - $229.32K/yr

... guide biocompatibility testing under GLP requirements. * Serve as a subject matter expert ... The ability to manage multiple projects simultaneously and work effectively in a matrixed ...

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Biocompatibility Manager information

What are the key skills and qualifications needed to thrive as a Biocompatibility Manager, and why are they important?

To thrive as a Biocompatibility Manager, you need expertise in toxicology, materials science, and regulatory standards, typically supported by a degree in a life science field and experience with medical device biocompatibility testing. Familiarity with ISO 10993 standards, risk assessment tools, and regulatory submission systems is essential. Strong analytical thinking, attention to detail, and effective communication skills help in collaborating with cross-functional teams and ensuring regulatory compliance. These skills and qualities are vital for ensuring product safety, regulatory approval, and successful market entry for medical devices.

What are the common challenges a Biocompatibility Manager faces when coordinating cross-functional teams during product development?

A Biocompatibility Manager often encounters challenges in aligning the priorities and timelines of various teams such as R&D, regulatory affairs, and quality assurance. Ensuring clear communication about testing requirements and regulatory updates is vital, as misunderstandings can lead to delays or non-compliance issues. Additionally, the manager must balance thorough risk assessments with project deadlines, all while staying current with evolving international standards. Effective collaboration and proactive problem-solving are key to overcoming these challenges and ensuring the safety and compliance of medical devices.

What does a Biocompatibility Manager do?

A Biocompatibility Manager oversees the evaluation and testing of medical devices and materials to ensure they are safe and compatible with human tissues. Their responsibilities include designing testing protocols, interpreting regulatory requirements, and ensuring compliance with international standards like ISO 10993. They work closely with research, development, and regulatory teams to address any risks related to biological safety. Their work is critical for gaining regulatory approvals and ensuring patient safety.

What is the difference between Biocompatibility Manager vs Biocompatibility Specialist?

AspectBiocompatibility ManagerBiocompatibility Specialist
CredentialsTypically requires a degree in life sciences or biomedical engineering; certifications like ISO 10993 are commonSimilar educational background; often holds certifications in biocompatibility testing
Work EnvironmentOversees teams, manages projects, and ensures compliance across departmentsPerforms testing, data analysis, and reports within labs or R&D settings
Industry UsageUsed in regulatory, quality assurance, and management roles within medical device companiesPrimarily involved in testing and technical analysis within laboratories

The main difference is that the Biocompatibility Manager oversees testing programs and compliance strategies, while the Biocompatibility Specialist focuses on conducting tests and technical analysis. Both roles require similar credentials but differ in scope and responsibilities.

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Biocompatibility Manager jobs near you
Senior Medical Device Toxicologist

Senior Medical Device Toxicologist

Geosyntec Consultants, Inc.

Seattle, WA • On-site, Remote

$209.06K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

This job post has expired today. Applications are no longer accepted.

Job description

Overview
Gradient, a Geosyntec Company, is seeking a Senior Medical Device Toxicologist to assist colleagues and clients in toxicological risk assessments and biological safety evaluations for medical devices. You will have the opportunity to work fully remote from your home-office in Tustin, California and join our growing practice supporting our Seattle, WA operations.
Gradient is an environmental and health risk sciences consulting firm specializing in environmental sciences, human and ecological risk sciences, product stewardship, and life sciences. Gradient's scientists have a variety of backgrounds in chemistry, engineering, toxicology, epidemiology, ecotoxicology, medical device and pharmaceuticals, exposure sciences, industrial hygiene, GIS, product safety and liability, and sustainability.
We invest in our people. Each employee is unique, and your career at Gradient will be too. We offer competitive pay and benefits, and well-being programs to support you and your family.
To Learn More Visit:: http://www.geosyntec.com/careers/
Essential Duties and Responsibilities
  • Possess in depth understanding of Biological Safety regulations (ISO 10993 and ISO 18562) and geography-specific requirements for both the USA and European Union to support regulatory submissions.
  • Review and analyze technical data from multiple sources to assess potential toxicological risks and compliance to current regulations.
  • Conduct strategic biological safety evaluation programs for medical devices that include: hazard identification, literature reviews, use of new and existing biological safety data, design of chemical characterization studies for extractables and leachables, and toxicological risk assessments.
  • Coordinate with external labs to communicate test methods, sample submission, and review of test lab reports.
  • Manage projects related to biomedical toxicological risk assessment and/or biocompatibility related projects.

Education and Licensure
  • Bachelor's degree in toxicology or related field. (required)
  • Advanced degree in toxicology or related field (strongly preferred)

Skills, Experience and Qualifications
  • At least 8 years (10+ preferred) in the field of medical device or pharmaceutical biocompatibility; or equivalent combination of education and experience (required)
  • Exceptional written and oral communication (required)
  • Excellent quantitative skills (required)
  • The ability to work independently in a challenging and fast-paced work environment (required)
  • Prior consulting or industry experience in medical device or pharmaceutical field, including managing projects with multiple staff (preferred)
  • Strong data management experience (preferred)
  • Experienced in medical device material selection and manufacturing processes to evaluate patient/product safety (preferred)

This opportunity will be posted for at least five days. Below are the potential compensation ranges that we in good faith believe are applicable for this role at the time of this posting and are only applicable for jobs to be performed in the specified location(s) below. The typical base salary range for this position is just one component of Geosyntec's total compensation package for employees. Actual compensation will be determined based on education, experience, skill set and location.
  • Minimum Salary: $129,105/year / Maximum Salary: $209,060/year (California, Washington)

We offer a comprehensive benefits package to all eligible employees including, 9 paid holidays, 2 floating holidays, a minimum of 8 sick days, and a minimum of 11 vacation days per year, in line with state or federal requirements. Employees (and their families) are offered medical, dental, vision, life, and disability insurance, 401(k), a variety of leaves of absences and other benefits to eligible employees.

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