Senior Toxicologist

 RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.

The 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.

Primary 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. 

Behaviours

• 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

Supervisory Responsibilities

• This position will have no supervisory responsibilities. 

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! 

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

Job Opportunity Verification

At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:

All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers

Every candidate going through the interview process will participate in a voice and/or video interview.

Exercise caution with unsolicited job offers or requests for sensitive information.