Marlboro, MA 01752
Job Title: Regulatory Analyst Specialist RA Specialists (Regulatory Analysts) because of a soon-to-be-changing EU spec for med devices.
Must have 8+ years prior RA experience and a minimum five years direct experience in an FDA or EU regulated environment, preferably with respect to the release of labeling and UDI (Unique Device Identifier) Contract assignment 6 months plus could go longer.
Bachelor s degree - Degree or background in life sciences, technical (engineering) or related field.
Project Management experience. PMP Certification is a bonus.
Experience with EU MDR/IVDR a bonus
Regulatory Affairs Certification(s) (U.S., EU or Global) desirable.
The incumbent s regulatory background should include the medical device and IVD.
Position requires a drug test and background check
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For more information contact our Wallingford office at 203-272-6780
If interested please send a resume to: