Galway Medical Device Toxicologist III G

Job description

The Medical Device Toxicologist III at Boston Scientific provides technical support for biocompatibility and toxicology processes to meet global business objectives. This position contributes to the biological evaluation of medical devices in support of new product development, sustaining activities, and global regulatory submissions. Additionally, this position may include the conduct of toxicological risk assessments based on data derived from extractables and leachables studies. The role applies established standards, procedures, and risk-based approaches to help ensure patient safety and product quality while enabling timely product development and regulatory decisions. Your responsibilities will include: Providing support for biocompatibility processes initiated by department management and ensuring biocompatibility and toxicology related information and data are accurate, reliable, and support business objectives as consistent with Global Preclinical objectives and Quality Management System requirements. Demonstration of a primary commitment to patient safety and product quality. Authoring biocompatibility and chemical characterization test plans, authoring biocompatibility assessments and reports, and assessing test data and reports as necessary to support business objectives. Authoring or assisting to author toxicological risk assessments, as assigned, to support divisional objectives. Providing informal guidance to new or less-experienced team members on established biocompatibility and chemical characterization processes, as appropriate. Maintenance of communication with internal customers on biocompatibility and toxicology issues, and supporting the resolution of straightforward to moderately complex issues related to biological evaluation, chemical characterization, and toxicological risk assessment. Consulting on biocompatibility, chemistry and toxicology testing and strategies related to new investigational and strategic device development programs during Technology and Product development programs (TDP/PDP). Apply working knowledge of regulatory requirements and internal procedures to support medical device submissions for assigned projects and divisions. Participating, as assigned, in a Biocompatibility Training Program for all functional groups of device development teams based on standards and regulatory requirements. Serving as a resource for factual biocompatibility and toxicology information for medical devices and pharmaceutical materials, which may include materials of animal origin, color additives, chemical exposure assessments, and other chemical toxicities. Advising on procedures, techniques, concepts and approaches used at divisional levels for biocompatibility and toxicology programs; identifying issues and escalating complex or unprecedented matters as appropriate. Required qualifications: An Honours Degree (Level 8) in Toxicology or closely related field (biology, chemistry, biochemistry, biomedical engineering). 3-5 years of related medical device / related industry experience. Knowledge of the biological evaluation of medical devices and / or drug-device combination products. Preferred qualifications: A Masters degree (Level 9) in Toxicology or closely related field (biology, chemistry, biochemistry, biomedical engineering). Will consider candidates with an Masters (Level 9) and 2+ years of related experience. A PhD degree in Toxicology or related field (biology, chemistry, biochemistry, biomedical engineering). Will consider candidates with an PhD and 1+ years of related experience. Applied knowledge and understanding of toxicology principles and best practices. Working knowledge of risk assessment methodologies, including the toxicological evaluation of medical device materials. Working knowledge of regulatory standards and global regulatory requirements with respect to medical device and combination products. Experience supporting GLP and nGLP studies Excellent written and verbal communication skills. Results and detail-oriented Able to multi-task while working against aggressive timelines. Comfortable in a dynamic environment and able to work with a moderate level of guidance, independently on assigned work, and collaboratively on teams. At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com . . Job Segment: Medical Device, Pharmaceutical, Biomedical Engineering, Scientific, Law, Healthcare, Science, Engineering, Legal Apply now » Apply Now Start apply with LinkedIn Please wait... Find similar jobs: All Jobs in Galway, Ireland, All Jobs in Cork, Ireland, All Jobs in Clonmel, Ireland Careers Home Top Jobs Searches View All Jobs Privacy Policy Terms of Use Copyright Notice Contact Us Corporate Home ©2017 Boston Scientific or its affiliates. All rights reserved. Cookie Consent Manager When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. Required Cookies These cookies are required to use this website and can't be turned off. Required Cookies Required Cookies Provider Description Enabled SAP as service provider We use the following session cookies, which are all required to enable the website to function: "route" is used for session stickiness "careerSiteCompanyId" is used to send the request to the correct data center "JSESSIONID" is placed on the visitor's device during the session so the server can identify the visitor "Load balancer cookie" (actual cookie name may vary) prevents a visitor from bouncing from one instance to another Cookies from provider SAPasserviceprovider are required and cannot be turned off Own Your Career Development Programs & Resources Learn New Skills Manage Your Talent Profile Our Core Competencies Promotions at BSC About Your Total Rewards Explore Departments Clinical Services Jobs Customer Service Jobs Finance Jobs Health Economics and Reimbursement Jobs Human Resources Jobs Information Technology Jobs Legal and Compliance Jobs Manufacturing and Operations Jobs Marketing and Communications Jobs Quality Jobs Regulatory Affairs Jobs Research and Development Jobs Sales Jobs Supply Chain and Distribution Jobs Leadership Opportunities US Medical Assembler Jobs View All Jobs Jobs by Location Our Inclusive Culture Diversity, Equity & Inclusion Inclusion Toolkit Inclusive Behaviors Assessment Connect with an ERG