Job Details:
Abbott Cardiovascular Systems, an Abbott Labs Co., located in Santa Clara, CA seeks qualified Sr RA Specialist. Prepare robust regulatory applications to US FDA or EU Notified Body to achieve business goals w/out negative impact to business ops. Master’s or foreign equivalent degree in Regulatory Affairs/Science, Pharmacy, Biomedical Engineering, Biology or in a closely related regulatory affairs/health science field of study (will accept a Bachelors degree with at least 5 years of related progressive professional experience in lieu of a Master’s degree). Each alternative requirement with an academic or industrial background in: (i) understanding, investigating and evaluating regulatory requirements in order to assess regulatory implications for approval, and to anticipate regulatory obstacles; (ii) providing regulatory representation and support for product review, product change, and product transfer through product lifecycle; (iii) supporting new product submissions/approval processes, including U.S. and EU submissions and approvals; (iv) replying to questions from regulatory bodies on both pending approvals and on-site audits; (v) supporting compliance with regulatory requirements, including EU Medical Device Regulations and ISO 13485. Employer will accept any suitable combination of education, training, or experience. An EOE. 40 hrs/wk. $125,715 - $167,200/yr.
How to Apply:
Send resumes to:
Abbott Laboratories
Attn: Elvia Salazar, Willis Tower
233 S. Wacker Drive, Floor 25, Dept. 32
Chicago, IL 60606
Refer to ad code: ABT-0030-ES
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