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. 

 

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.