... management process * ISO TS 21726:2019, Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device ...
... management process * ISO TS 21726:2019, Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device ...
Pacific BioLabs is an independent CRO providing cGMP/GLP testing in toxicology, biocompatibility ... Study Coordination & Timeline Management * Support laboratory analysts by ensuring samples are ...
Pacific BioLabs is an independent CRO providing cGMP/GLP testing in toxicology, biocompatibility ... Study Coordination & Timeline Management * Support laboratory analysts by ensuring samples are ...
This position plays a critical part in the biocompatibility and analytical testing pipeline for ... Study Coordination & Timeline Management * Support laboratory analysts by ensuring samples are ...
This position plays a critical part in the biocompatibility and analytical testing pipeline for ... Study Coordination & Timeline Management * Support laboratory analysts by ensuring samples are ...
This position plays a critical part in the biocompatibility and analytical testing pipeline for ... Study Coordination & Timeline Management * Support laboratory analysts by ensuring samples are ...
This position plays a critical part in the biocompatibility and analytical testing pipeline for ... Study Coordination & Timeline Management * Support laboratory analysts by ensuring samples are ...
PD Program Manager
$163K - $204K/yr
FDA QSR 21 CFR 820, ISO 13485 (Risk Mgmt.), ISO 10993 (Biocompatibility), IEC 62366 (Usability ... Engineering), IEC 60601-1 (Electrical Safety), EN 14971 (Risk Mgmt.) and EN 62304 (Software ...
PD Program Manager
$163K - $204K/yr
FDA QSR 21 CFR 820, ISO 13485 (Risk Mgmt.), ISO 10993 (Biocompatibility), IEC 62366 (Usability ... Engineering), IEC 60601-1 (Electrical Safety), EN 14971 (Risk Mgmt.) and EN 62304 (Software ...
Senior Biological Safety Engineer
Murrysville, PA · On-site
$102K - $163K/yr
... biocompatibility training programs, work within a team environment to peer-review deliverables, and provide clear, consistent weekly project status updates to stakeholders. * Managing and ...
Senior Biological Safety Engineer
Murrysville, PA · On-site
$102K - $163K/yr
... biocompatibility training programs, work within a team environment to peer-review deliverables, and provide clear, consistent weekly project status updates to stakeholders. * Managing and ...
This role requires deep expertise in medical device development, regulatory pathways, operations, sterilization, biocompatibility, and cross-functional project management. The Senior Project Manager ...
This role requires deep expertise in medical device development, regulatory pathways, operations, sterilization, biocompatibility, and cross-functional project management. The Senior Project Manager ...
This role requires deep expertise in medical device development, regulatory pathways, operations, sterilization, biocompatibility, and cross-functional project management. The Senior Project Manager ...
This role requires deep expertise in medical device development, regulatory pathways, operations, sterilization, biocompatibility, and cross-functional project management. The Senior Project Manager ...
Toxicologist
Bethesda, MD · On-site
... management process * ISO TS 21726:2019, Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device ...
Toxicologist
Bethesda, MD · On-site
... management process * ISO TS 21726:2019, Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device ...
PD Program Manager
Lafayette, CO · On-site
$163K - $204K/yr
FDA QSR 21 CFR 820, ISO 13485 (Risk Mgmt.), ISO 10993 (Biocompatibility), IEC 62366 (Usability ... Engineering), IEC 60601-1 (Electrical Safety), EN 14971 (Risk Mgmt.) and EN 62304 (Software ...
PD Program Manager
Lafayette, CO · On-site
$163K - $204K/yr
FDA QSR 21 CFR 820, ISO 13485 (Risk Mgmt.), ISO 10993 (Biocompatibility), IEC 62366 (Usability ... Engineering), IEC 60601-1 (Electrical Safety), EN 14971 (Risk Mgmt.) and EN 62304 (Software ...
This role requires deep expertise in medical device development, regulatory pathways, operations, sterilization, biocompatibility, and cross-functional project management. The Senior Project Manager ...
This role requires deep expertise in medical device development, regulatory pathways, operations, sterilization, biocompatibility, and cross-functional project management. The Senior Project Manager ...
Manager, Microbiology & Sterility
$140K - $170K/yr
Oversee Microbiological/Biocompatibility efforts in support of NPD/Sustaining Engineering efforts ... Strong project management skills with the ability to prioritize for maximum results (multi-task ...
Manager, Microbiology & Sterility
$140K - $170K/yr
Oversee Microbiological/Biocompatibility efforts in support of NPD/Sustaining Engineering efforts ... Strong project management skills with the ability to prioritize for maximum results (multi-task ...
PD Program Manager
$163K - $204K/yr
FDA QSR 21 CFR 820, ISO 13485 (Risk Mgmt.), ISO 10993 (Biocompatibility), IEC 62366 (Usability ... Engineering), IEC 60601-1 (Electrical Safety), EN 14971 (Risk Mgmt.) and EN 62304 (Software ...
PD Program Manager
$163K - $204K/yr
FDA QSR 21 CFR 820, ISO 13485 (Risk Mgmt.), ISO 10993 (Biocompatibility), IEC 62366 (Usability ... Engineering), IEC 60601-1 (Electrical Safety), EN 14971 (Risk Mgmt.) and EN 62304 (Software ...
Research Fellow, Medical Device Toxicologist
Rochester, NY · On-site
$150K - $200K/yr
Manage team responsible for medical device biocompatibility support * Responsible for project strategies, risk assessments, biocompatibility evaluation plans and reports for medical devices * Ensures ...
Research Fellow, Medical Device Toxicologist
Rochester, NY · On-site
$150K - $200K/yr
Manage team responsible for medical device biocompatibility support * Responsible for project strategies, risk assessments, biocompatibility evaluation plans and reports for medical devices * Ensures ...
... management process * ISO TS 21726:2019, Biological evaluation of medical devices -- Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device ...
Quick apply
... management process * ISO TS 21726:2019, Biological evaluation of medical devices -- Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device ...
Sr. Engineer, Medical Device R&D
Minneapolis, MN · On-site
$115K - $140K/yr
Strong Device Design Control and Risk Management * Biocompatibility research and testing experience is ideal * Understanding and experience with Design Control and V&V
Quick apply
Sr. Engineer, Medical Device R&D
Minneapolis, MN · On-site
$115K - $140K/yr
Strong Device Design Control and Risk Management * Biocompatibility research and testing experience is ideal * Understanding and experience with Design Control and V&V
Coordinates the biocompatibility testing of new products and materials. Ensure compliance to Good ... Manages EO Sterilization Validations, Out of Tolerance Investigations, Bacterial Endotoxin Testing.
Coordinates the biocompatibility testing of new products and materials. Ensure compliance to Good ... Manages EO Sterilization Validations, Out of Tolerance Investigations, Bacterial Endotoxin Testing.
$150K - $200K/yr
Manage team responsible for medical device biocompatibility support * Responsible for project strategies, risk assessments, biocompatibility evaluation plans and reports for medical devices * Ensures ...
$150K - $200K/yr
Manage team responsible for medical device biocompatibility support * Responsible for project strategies, risk assessments, biocompatibility evaluation plans and reports for medical devices * Ensures ...
Senior Engineer, Mechanical Engineering- CA
San Diego, CA · On-site
$140K - $160K/yr
The successful candidate will drive mechanical architecture decisions from concept through verification, balancing biocompatibility, manufacturability, thermal management, and regulatory requirements ...
Quick apply
Senior Engineer, Mechanical Engineering- CA
San Diego, CA · On-site
$140K - $160K/yr
The successful candidate will drive mechanical architecture decisions from concept through verification, balancing biocompatibility, manufacturability, thermal management, and regulatory requirements ...
Senior Biological Safety Engineer
Murrysville, PA · On-site
$102K - $163K/yr
... biocompatibility training programs, work within a team environment to peerreview deliverables, and provide clear, consistent weekly project status updates to stakeholders. * Managing and prioritizing ...
Senior Biological Safety Engineer
Murrysville, PA · On-site
$102K - $163K/yr
... biocompatibility training programs, work within a team environment to peerreview deliverables, and provide clear, consistent weekly project status updates to stakeholders. * Managing and prioritizing ...
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?
| Aspect | Biocompatibility Manager | Biocompatibility Specialist |
|---|---|---|
| Credentials | Typically requires a degree in life sciences or biomedical engineering; certifications like ISO 10993 are common | Similar educational background; often holds certifications in biocompatibility testing |
| Work Environment | Oversees teams, manages projects, and ensures compliance across departments | Performs testing, data analysis, and reports within labs or R&D settings |
| Industry Usage | Used in regulatory, quality assurance, and management roles within medical device companies | Primarily 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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Posted 7 days ago
Job description
Toxicologist Subject Matter Expert for FDAÂ
Educational Requirements:Â Applicants should possess a PhD in Toxicology, or Biology and Chemistry with the ability to demonstrate mastery of principles, practices, and theories in the field of toxicology and risk assessment. This candidate must serve as a technical authority in the scientific analysis of the safety and effectiveness of medical devices, and provide an authoritative analysis of scientific data submitted to the Agency to support scientific evaluations required for medical device review by FDA.
Qualifications:Â
- A PhD, or equivalent advanced degree, from an accredited or pre-accredited university in Toxicology, or Biology and Chemistry.
- A minimum of five years of experience conducting assessments of risks to human health from exposure to chemicals, chemical hazard identification, and selection of studies for quantitative dose-response and exposure assessments, including assessment of adverse responses and relevant mechanism(s) of material/tissue interactions associated with extractables and leachables from polymers and metal alloys using approaches within the disciplines of toxicology, immunotoxicology, and genetic toxicology.
- Experience related to medical devices is highly desirable.
- Knowledge of the scientific principles, theories and practices associated with the discipline of toxicology and the assessment of risks to human health posed by chemicals, extractables, and leachables.
- Experience with in silico and computational methodologies for toxicological risk assessment would be beneficial, and evidence of a strong track record of research and peer-reviewed publications in chemical hazard identification, toxicology, and risk assessment could also be beneficial.
- Familiar with the applicable guidances and standards, including, but not limited to the following:
- FDA Biocompatibility Guidance LINK
- Basics of Biocompatibility: Information Needed for Assessment by the FDA (website)
- Standards:
- ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-17:2002, Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
- ISO 10993-18:2020, Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
- ISO TS 21726:2019, Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
- ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk (2017; R2018)
Additional Information:
- Board certification or related, relevant certifications are highly preferred, e.g., American Board of Toxicology, Academy of Toxicological Sciences, etc.
- The successful candidate must be able to function independently and as part of matrixed teams involving federal and other contract staff of various disciplines and backgrounds.
- Must be able to successfully work remotely; position is 100% telecommuting.
- Must possess excellent communication skills (written, verbal) and facility with MS Office suite programs (word, PowerPoint, excel, etc.)
Must be a US Citizen or Full Green Card holder.