Research Specialist / Manager - Biocomp SME

Research Specialist / Manager - Biocomp SME

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Research Specialist / Manager - Biocomp SME

Conduct Biological Safety Risk Assessments on orthopedic device in accordance with ISO 10993 and EU MDR.
Plan and manage in-vivo and in-vitro biocompatibility and chemical characterization studies that comply with industry standards (ASTM, ISO )
Write toxicological assessment and biological evaluation reports
Preparation of responses to inquiries from regulatory agency (ex. FDA, BSI, CFDA, PMDA.) in a timely and thorough manner
Work Collaboratively with scientists, engineers, and regulatory specialists in multidisciplinary project teams
Proactively identify future biological safety challenges and develop strategies to address them
Review and prepare procedures to keep pace with standards development
Represent the company via presentations to groups of experts, societies, regulatory bodies and at international meetings.
Maintain relevant scientific and medical knowledge by attending conferences, courses and meetings
Help to develop and generate material for staff training and data presentations
Provides support for key opinion leaders
This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA. Overall Work Experience > 4 years. Relevant Experience on above areas > 2 years
Educational qualification: Masters in chemistry/biochemistry/pharma with chemistry background/toxicologist
Manufacturing Engineering, Mechanical engineering with manufacturing experience

CMR/ED/Animal Tissue evaluation experience

REACH, ECHA, CAS Keywords

Material evaluation for biocompatibility. (Raw material and contact material)

Knowledge of manufacturing process of medical devices

Extensive experience of biological evaluation + ISO 10993-1 standard

Chemical analysis for any medical device

Experience in toxicology and toxicological risk analysis (not neccesarily DABT/ERT certified)

Material supplier coordination experience

Educational Requirements :-

1) Biotechnology
2) ERT/DABT
3) Masters/ Ph.D. Required Skillset(s) Has shown outstanding competencies as subject matter expert in the following areas
Current global toxicological guidelines (USP, JP, Ph., Eur., etc.)
ISO 10993 standards
EU MDR requirements
Risk assessments of manufacturing contact materials
Working knowledge of analytical chemistry
Ability to work within a multidisciplinary team setting with good interpersonal skills
Excellent oral and written communication skills
Has a comprehensive record of external and internal training in area of competence
Has proven competency in presenting subject matter to expert groups and key opinion leaders in a clear and convincing matter.
Strong problem solving skills. Able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely manner
Demonstrates strong written and verbal communication skills including presentation skills. Has ability to tailor the information to the audience and answer with confidence and authority scientific questions
Handles discussions of complex topics with confidence
Demonstrates ability to discuss sensitive information with and tailor communication style to listeners' perspectives, including management, surgeons, and external contacts Responsibilities Conduct Biological Safety Risk Assessments on orthopedic device in accordance with ISO 10993 and EU MDR.
Plan and manage in-vivo and in-vitro biocompatibility and chemical characterization studies that comply with industry standards (ASTM, ISO )
Write toxicological assessment and biological evaluation reports
Preparation of responses to inquiries from regulatory agency (ex. FDA, BSI, CFDA, PMDA.) in a timely and thorough manner
Work Collaboratively with scientists, engineers, and regulatory specialists in multidisciplinary project teams
Proactively identify future biological safety challenges and develop strategies to address them
Review and prepare procedures to keep pace with standards development
Represent the company via presentations to groups of experts, societies, regulatory bodies and at international meetings.
Maintain relevant scientific and medical knowledge by attending conferences, courses and meetings
Help to develop and generate material for staff training and data presentations
Provides support for key opinion leaders
This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.
Shows leadership skills and initiative