Senior Toxicologist

Summary

Join RQM+, a leading MedTech service provider, as a Toxicologist. You will provide technical support, reviewing and analyzing data to assess toxicological risks and ensure compliance with global regulations. Responsibilities include conducting toxicological risk assessments, authoring responses to regulatory agencies, and collaborating with internal and external partners. This role requires a Bachelor's degree in Toxicology or a related field, along with significant experience in medical device toxicological risk assessment and technical writing. Preferred qualifications include a Master's degree and experience with regulatory agencies. RQM+ offers a rewarding work environment with an industry-leading compensation package and a focus on work-life balance.

Requirements

• Possess a Bachelor level degree in Toxicology or closely related field
• Have a Master’s degree or equivalent in toxicology or related field
• Demonstrate 5 years technical/scientific writing experience in the medical device industry
• Have experience with medical device toxicological risk assessment
• Possess chemical characterization testing and biological evaluation of medical devices and / or drug-device combination products experience
• Have knowledge of US FDA chemical characterization and biological evaluation requirements
• Possess advanced computer skills including Microsoft business applications
• Have excellent written and verbal communication skills
• Demonstrate strong logic, and ability to understand and assimilate complex testing concepts
• Establish and maintain effective relationships with customers and gain their trust and respect
• Have experience working collaboratively with clients, peers, and cross-functional teams
• Demonstrate high performance orientation, detail orientation, and strong organizational skills
• Have the ability to problem-solve, think strategically, and respond appropriately to customer needs
• Have the ability to develop and deliver presentations
• Be a self-motivated individual with a “lead by example” approach that endorses the company’s values and culture
• Demonstrate a strong commitment to professional and scientific integrity, compliance, and patient safety
• Be board certified (DABT) toxicologist or in process of being certified

Responsibilities

• Conduct 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)
• Perform hazard assessments: Literature or computational modelling compilation for individual chemicals
• Learn Biological Safety regulations ISO 10993 and ISO 18562 and other geographic specific requirements for both US and EU to support regulatory submissions
• 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
• Coordinate with internal laboratory to communicate review of test lab reports
• Develop and author responses to regulatory agencies
• Work with internal colleagues on nonclinical (toxicological) risk assessment, and work with external partners, scientific societies, and regulators globally

Preferred Qualifications

• Have 7 years of regulatory or product development experience in the medical device industry
• Have familiarity with European notified body requirements
• Have direct interface with regulatory agencies

Benefits

• Industry leading compensation package
• Focus on work life balance
• Ongoing learning and development opportunities