Senior Manager - Biocompatibility and Toxicology (Remote)
Senior Manager - Biocompatibility and Toxicology (Remote) Stryker is hiring a Senior Manager - Biocompatibility and Toxicology to support our Trauma & Extremities business! In this role, you will lead and manage a team of biocompatibility and toxicology experts, providing support and direction to scientists and engineers in the field of Biocompatibility and Toxicology. You will also collaborate with internal and external labs to support biological safety testing and ensure compliance with industry standards. What you will do:
- Partner with cross-functional project teams to define evaluation/verification strategies of medical devices.
- Identify new/emerging regulatory requirements and customer needs and develop strategies that enable business to react in a compliant and efficient manner.
- Proactively identify risks and deficiencies in product designs and manufacturing processes/supply chain and collaborate with the business to drive mitigation strategies.
- Lead projects to increase capabilities that enable cost savings, speed to market, and efficient use of resources.
- Interpret, assess, analyze, and apply international standards (i.e. cleaning, disinfection, and biocompatibility) to drive best-in-class processes.
- Lead the development or revision of quality system procedures. This may include serving as a divisional and/or corporate process owner.
- Support regulatory audits, FDA interactions, and customer inquiries
- Represent the company on a scientific level at international meetings. This may involve presentation to regulatory authorities and/or writing scientific papers for publication.
What you will need: Required
- Bachelor’s degree in Biology, Microbiology, Chemistry, Biomedical Engineering or a related field
- 10+ years of experience in Biocompatibility, toxicology or a similar field
- 5+ years of experience leading teams
Preferred
- Expert knowledge of the field of biocompatibility for medical devices and applicable standards and regulations (i.e. ISO 10993)
- Expertise and ability to lead teams in implementing FDA, GMP, ISO, and other medical device regulatory requirements.
- High degree of expertise with biocompatibility requirements, test methods, and practices within a regulated environment.
- Technical proficiency with reading, interpreting, and contributing to development of standards and regulations.
- Technical proficiency with analyzing and interpreting laboratory and validation test results and with resolving test failures.
$129,600.00 - $286,500.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors. Apply Job!