Job Description The principal Toxicologist is responsible for project planning, tracking and reporting to the European- and Global headquarters with regards to assessment of the biological safety devices.
He/ she will conducts toxicological risk assessments based on data derived from extractables and leachable studies, in support for new product development, product life cycle or support of regulatory submissions.
He/ she will collaborate in project work with the chemistry lab, and other departments like research, process engineering, manufacturing, quality and regulatory as well as with other sites and external suppliers (list is not exhaustive).
He/ she will servo also as a global Subject Matter Expert (SME) to R&D, Operations, Marketing, Sales, Clinical Affairs and Regulatory (list is not exhaustive).
General responsibilities: Conduct Biological Safety Risk Assessments on orthopedic device in accordance with ISO 10993 and EU MDR considering interpretation by international agencies and regulations such as FDA; Continuous exploration and education in the field of toxicological risk assessment (i.e.
in-silico, read across, in vitro test method, 3R methodology); Continuous exploration and education in the field of biological endpoint testing; Resource for toxicological risk assessments; Internal technical document creation and approval; Participate in internal and external audits as subject matter expert; Create Technical Reports, specifications, and other mandatory documents for regulatory submissions; Biocompatibility assessment and organization of respective testing; Review and preparation of procedures to keep pace with AAMI / ISO standard development; Represent the company via presentations to groups of experts, societies, regulatory bodies and at international meetings; Support the training of internal and external personnel; Develop and generate material for staff training and data presentations; Maintain relevant scientific and medical knowledge by attending conferences, courses and meetings; Educate internal colleagues across departments and divisions in the area of biological evaluations and toxicological topics; Preparation of responses to inquiries from regulatory agency (ex.
FDA, BSI, CFDA, PMDA.)
in a timely and thorough manner.
Qualifications Professional experience: Minimum of 7 years industrial experience, preferably in implantable medical device industry (orthopedic devices preferred) and/or at contract laboratories; Has achieved a seniority level by leading complex projects of high business relevance in the medical device / pharmaceutical industry; Has shown outstanding competencies as SME; Has a comprehensive record of external and internal trainings in his area of expertise; Has proven competence in presenting scientific data to expert groups and key opinion leaders in a clear and convincing manner; Has experience in conveying complex scientific topics in a clear and comprehendible fashion; Has shown outstanding competencies as subject matter expert in the following areas: - Of current global toxicological guidelines (USP, JP, Ph., Eur., etc.)
- ISO 10993 standards, EU MDR requirements; - Risk assessments of manufacturing contact materials.
Special expertise: Demonstrates ownership for integrity of own work and the work of the project team Technical advisor.
Can serve as a mentor for other group members; Definition and justification of testing strategies including rationales for omitting of test endpoints and communication of the critical path for the corresponding project; Has an excellent knowledge of industry standards (ANSI, AAMI, ISO, PDA, etc.
); Applied knowledge and understanding of toxicology principles and best practices.
Personal skills requirements: Demonstrates ownership for integrity of their own work and the work of the project team; Works independently – anticipates issues; Is watchful for areas of improvement for the department or development procedures and volunteers to take action; Strong problem solving skills.
Able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely manner; Goes beyond existing knowledge base and expands our understanding, methods, and procedures, leaving a base for others to utilize and build upon; Demonstrates ability to balance needs of all departments to meet customer expectations and project schedules; Demonstrates an ability to utilize resources efficiently; Demonstrated ability to represent the company to accomplish objectives even during disagreements; Is professional, concise, and sensitive in accomplishing objectives.
Is able to diplomatically negotiate with a requester regarding what they want in design, process, scope or timetable; 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; Shows leadership skills and initiative.
Education: Minimum educational requirement is a Master degree in relevant scientific disciplines (e.g.
toxicology or Master of Advanced Studies (MAS)); An advanced degree or significant experience in the field of medical devices biocompatibility (application of ISO 10993 series) is preferable; Any toxicology specific certifications are a plus (ERT, DABT, country-specific registration.
Travel Requirements 10% Additional Information Why this organization?
If you become a companies team member, you can expect a career that challenges and stretches you, motivates and rewards you and supports and encourages you to reach your potential.
They believe in the power of them, which means that they are stronger together and they are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.
Salary The company offers you a challenging position with good career prospects in a fast growing international business and a competitive remuneration package, good pension plan & bonus scheme.
How to Apply: If you are interested and you meet all the above requirements please send your English resume via the 'Apply' button or call for further inquiries to Noblesse Recruitment; Monique Nobel at +31 641 576 904 ( www.noblesserecruitment.nl ).