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Senior Regulatory Affairs Specialist-Animal Tissue
3 months ago
Overview:
Candidate will be responsible for regulatory activities related to Animal Tissue
Responsibilities:The Sr. Regulatory Affairs Specialist Animal Tissue will report to the VP of Regulatory Affairs and have the following primary responsibilities:
- 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.
- Other responsibilities assigned by the management.
- Bachelor's degree from four-year college or university, preferably in biology, microbiology, virology, animal science, or veterinary.
- 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.
- Fluent in English
- Ability/experience to understand scientific/technic aspects of the medical devices.
Able to travel to the animal tissue suppliers
EEO Statement:In order to provide equal employment and advancement opportunities to all individuals, employment decisions at LeMaitre Vascular will be based on merit, qualifications, and abilities. LeMaitre Vascular does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, breastfeeding or related medical conditions, religious dress, military or veteran status or any other characteristic protected by law.
This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination, and access to benefits and training.
Applicants with disabilities may contact LeMaitre HR coordinators via telephone, fax, e-mail, and other means to request and arrange for accommodations. If you need assistance to accommodate a disability, you may request an accommodation at any time. Please contact LeMaitre HR at HR@lemaitre.com.
