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Reference Number:
RegAff
Job Description:
Regulatory Affairs Specialist in the Boston area.
Experience Level:
Unspecified
Requirements:
Medical Device environment is highly preferred.
***International experience is required***
***Hands on experience putting regulatory submissions together
? Responsible for US and International product submission/registration activities, assisting in meeting various government regulations: USA, Europe and other International Sites.
? Activities may include establishing, planning and executing various regulatory compliance activities. Fulfills selected Quality System requirements as described within Quality Systems Manual. Fulfills selected requirements under the European MDD as defined within SOPs and other documents.
? Determine/document appropriate regulatory strategy for proposed new products and initiate necessary activities.
? Prepare and submit registration and technical information in support of international marketing.
Required Skills:
? Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline.
? Professional certification(s) preferred. 5-8 years Regulatory Affairs medical industry experience.
? Medical Device experience required. Strong technical knowledge of medical products.
? Demonstrated success in management of regulatory submissions activities.
? Thorough understanding of global regulations.
? Strong technical understanding of relevant procedures, practices, and associated medical terminology.
? Strong knowledge of clinical trial strategy and study design, and sponsor reporting requirements.
? Thorough knowledge of product development process and design control.
? Excellent research and analytical skills. Ability to manage multiple projects.
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