Senior Regulatory Affairs Specialist
Invivoscribe San Diego, CA
- Expired: March 25, 2021. Applications are no longer accepted.
Invivoscribe has long established itself as a company built on integrity, innovation, and collaboration. As a team, we develop products and services that improve blood cancer diagnostics. For 25 years, we have stood at forefront of precision diagnostics, and we're just getting started!We are looking to add a Senior Regulatory Affairs Specialist will help develop the strategic direction and execute the tactical operational aspects of regulatory compliance and submissions for drug-device combination products.
S/he will assure regulatory submission projects are completed on time and that related development files are maintained.Core Responsibilities Include: Responsible for generating submissions (Investigational Medicinal Product Dossier (IMPD), New Drug Application (NDA), Investigational New Drug (IND), etc.) to the FDA, NB and ROW agencies. Assess appropriateness of Design Control documents including discovery, CMC and clinical development. Supports IVD projects and...
submissions. Submits required clinical trial progress reports. Submits required adverse event reports.
Submits required annual reports. Provides regulatory guidance to other departments. We Bring: A beautiful modern facility centrally located in San Diego County, with many jobs conducive to a hybrid work from home arrangement.
A well-stocked breakroom with hot and cold beverages, snacks, refrigerator and pantry items to get you through the day. Competitive salaries and bonus program, amazing benefit options, a 401k plan with a fully vested employer match, and generous time off benefits that include floating holidays enabling you to take that year-end holiday week, or perhaps a day at the beach! Opportunities to contribute, to learn, to grow, to make friends.You Bring: BS.
degree in Chemistry, Engineering, Biology, or scientifically related field with 5+ years' experience in a Regulatory department (medical devices or pharmaceuticals.) and 3+ years' experience with drugs, biologics, and/or combination products. Equivalent combination of education and experience will be considered. Demonstrated experience with all levels of regulatory submissions - IDE/IND, PMA, 510(k), NDA, etc.
with knowledge of international regulatory processes preferred. Ability to inform and educate personnel on regulations and policies that impact company's products and operations. Proficient in Microsoft Office Suite (Word, Outlook, Excel and PowerPoint), and the ability to learn new software programs
AddressSan Diego, CA
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