Senior Regulatory Affairs Specialist
Position: Senior Regulatory Affairs Specialist
Location: San Diego, CA
Posted: June 28, 2021
Invivoscribe is an industry pioneer in oncology diagnostics, dedicated to improving the standard of global healthcare for over 25 years. Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services. We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used in over 160 countries. Our global network of laboratories offer next generation molecular and flow cytometry panels to support our drug development entity and accelerate clinical trials. Our harmonized clinical laboratories offer a menu focused on clinically significant biomarkers which support therapeutic decisions, minimal residual disease (MRD) monitoring, patient stratification, trial enrollment, and the development of companion diagnostics.
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.
- 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.
- 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.