Senior Regulatory Affairs Specialist-Animal Tissue

LeMaitre Vascular • Burlington, MA

370d

About The Position

The Sr. Regulatory Affairs Specialist - Animal Tissue will be responsible for regulatory activities related to animal tissue for our products. This position will report to the VP of Regulatory Affairs and will involve managing all activities and tasks associated with animal tissue, ensuring compliance with relevant regulations and guidance.

Requirements

• Bachelor's degree from a four-year college or university, preferably in biology, microbiology, virology, animal science, or veterinary.
• Familiarity with ISO 22442 requirements and its application in medical devices.
• At least 3 years of experience working with animal tissue products.
• Ability to read, analyze, and interpret technical procedures and regulations.
• Fluency in English.
• Ability/experience to understand scientific/technical aspects of medical devices.

Responsibilities

• Manage all activities/tasks related to animal tissue for our products.
• Respond to regulatory authorities regarding any questions related to animal tissue.
• Perform annual literature reviews for compliance with animal tissue regulations and guidance.
• Conduct audits of the animal tissue suppliers.
• Fulfill other responsibilities assigned by management.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 251-500 employees