The Senior Toxicologist provides technical support to review and analyze technical data to assess potential toxicological risks and compliance to current global regulations and to meet global business objectives. Additionally, this position is responsible for the biological evaluation, including the conduct of toxicological risk assessments based on data derived from our internal extractables and leachable studies. The Toxicologist will develop and author responses to regulatory agencies and will work with internal colleagues on nonclinical (toxicological) risk assessment, and work with external partners, scientific societies, and regulators globally.
Responsibilities:
- Toxicological risk assessment of chemical characterization (or extractables/leachables, or E&L) data for medical devices (this includes exposure estimation, hazard assessment, read across as needed, margin of safety calculation, risk assessment)
- Hazard assessments: Literature or computational modelling compilation for individual chemicals
- Learn Biological Safety regulations ISO 10993 and ISO 18562and other geographic specific requirements for both US and EU to support regulatory submissions.
- FDA (CDRH) and EU MDR focus
- Ability to conduct biological safety evaluation programs for medical devices that include literature review, hazard identification, use of new and existing biological safety data, design of chemical characterization studies for extractable and leachables and toxicological risk assessments.
- Ability to coordinate with internal laboratory to communicate review of test lab reports.
- Board certified (DABT) toxicologist or in process of being certified.
- Experience with medical device toxicological risk assessment is critical.
Requirements:
- Bachelor level degree in Toxicology or closely related field.
- Master’s degree or equivalent in toxicology or related field
- Demonstrated 5 years technical/scientific writing experience in the medical device industry required.
- 7 years of regulatory or product development experience in the medical device industry preferred.
- Chemical characterization testing and biological evaluation of medical devices and / or drug-device combination products experience required.
- Knowledge of US FDA chemical characterization and biological evaluation requirements required. Familiarity with European notified body requirements preferred. Direct interface with regulatory agencies preferred.
- Advanced computer skills including Microsoft business applications.
- Excellent written and verbal communication skills.
- Strong logic, and ability to understand and assimilate complex testing concepts.
- Establishes and maintains effective relationships with customers and gains their trust and respect.
- Experience working collaboratively with clients, peers, and cross-functional teams.
- High performance orientation, detail orientation, and strong organizational skills.
- Ability to problem-solve, think strategically, and respond appropriately to customer needs.
- Ability to develop and deliver presentations.
- Self-motivated individual with a “lead by example” approach that endorses the company’s values and culture.
- Strong commitment to professional and scientific integrity, compliance, and patient safety.
Behaviors
- Action-Oriented, Analytical Mindset, Approachability, Business Acumen, Career Ambition, Composure, Courage, Customer Focus, Decision Quality, Detailed Oriented, Communication, Integrity & Trust, Interpersonal Savvy, Planning, Prioritizing, Time Management
