Our client a Major Multinational based here in Galway City are looking to expand, and are seeking applications from a suitably qualified and experienced Medical Device Toxicologist II (defined-term).
Provides support for the biocompatibility and toxicology processes and related technical support to assigned business divisions in support of new product development, regulatory submissions, and manufacturing and engineering changes to meet business objectives. Responsible for the conduct of Chemical Safety Assessments to evaluate potential extractables, leachables, and residuals and assessment of the potential for patient safety impacts related to these exposures.
- Provides support for biocompatibility processes initiated by department management and ensure 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.
- Demonstrates a primary commitment to patient safety and product quality.
- Under direction and mentorship of more senior staff author Chemical Safety Assessments and toxicology memos as necessary to support divisional objectives.
- Completes biocompatibility test plans, organize testing at external test laboratories, and assessing test data. Review and completion of Biocompatibility Assessments and Reports and reports as necessary to support business objectives, including authoring such reports.
- Provides input on the regulatory requirements related to medical device submissions. on procedures, techniques, concepts and approaches used at divisional levels for biocompatibility and toxicology programs
- Serves as a resource for biocompatibility and toxicology information for medical devices and pharmaceutical materials, which may include issues related to materials of animal origin, colorant additives, exposure assessments of chemicals, and other chemical toxicities as assigned.
- Communicates with internal customers on biocompatibility and toxicology issues and supports problem solving and resolution related to chemical risk assessments and biocompatibility assessments as assigned.
- Provides input on biocompatibility, chemistry and toxicology testing related to new investigational and strategic device development programs during Technology and Product development programs (TDP/PDP)
- Participates in a Biocompatibility Training Program for all functional groups of device development teams based on standards and regulatory requirements.
- Plans, organizes, and prioritises own daily work routine to meet established schedule with guidance from manager.
- Receives general supervision. Makes recommendations that may be reviewed by manager. May exercise authority within limits. May seek guidance in resolving problems.
- Begins establishing and cultivating internal business relationships to facilitate completion of tasks. May participate in project teams.
- Participates in the completion of departmental projects and goals. Errors in judgment or failure to achieve results would normally require an expenditure of resources to rectify.
- Engages with internal company and occasional external contacts. Uses discretion, diplomacy and tact in interactions.
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- BSc in a Science related discipline e.g. Toxicology, Chemistry or Biomedical Sciences.
- 1-3 years’ experience in medical device, pharmaceutical or related industry.
- General knowledge and application of technical and business concepts, procedures, and practices. Interprets company policies and procedures to resolve issues. Beginning knowledge of industry practices and standards. Knowledge of 10993 and advantage.
- Experience applying professional concepts and company policies and procedures, analyses data or situations, and exercises judgment to recommend solutions to solve problems. Follows standard practices and procedures in analysing situations or data from which answers can be obtained.
- Excellent attention-to-detail.
- Demonstrates business writing, proofreading and editing skills.
- Knowledge of internal company and occasional external contacts. Uses discretion, diplomacy and tact in interactions.
- Strong communication and influencing skills.
For a confidential discussion and for more information please contact Michelle Mc Inerney
091 706 717