RQM+ is hiring a
Senior Toxicologist

Summary

The Senior Toxicologist position is a technical role that involves assessing potential toxicological risks for medical devices and ensuring compliance with global regulations. The role requires a Board-certified toxicologist or someone in the process of becoming certified, with at least 5 years of technical/scientific writing experience in the medical device industry.

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
• 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

Responsibilities

• Toxicological risk assessment of chemical characterization (or extractables/leachables, or E&L) data for medical devices
• 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
• Conduct biological safety evaluation programs for medical devices
• Coordinate with internal laboratory to communicate review of test lab reports

Preferred Qualifications

Direct interface with regulatory agencies preferred

Benefits

Board certified (DABT) toxicologist or in process of being certified