Senior Regulatory Affairs Specialist-Animal Tissue

Title: Senior Regulatory Affairs Specialist-Animal Tissue
Location: Burlington MA
Schedule: Monday through Friday on site
Terms: Direct Hire

Education:

Bachelor's degree from four-year college or university, preferably in biology, microbiology, virology, animal science, or veterinary.

Requirements:
Candidate will be responsible for regulatory activities related to Animal Tissue
Familiar 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.
Ability/experience to understand scientific/technic aspects of the medical devices.
Able to travel to the animal tissue suppliers

Responsibilities:
Will report to the VP of Regulatory Affairs
Responsible for managing all activities/tasks related to animal tissue for our products.
Respond to regulatory authorities of any questions related to animal tissue.

Perform annual literature reviews for compliance with animal tissue regulations and guidance.
Perform audit of the animal tissue suppliers.

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