Senior Regulatory Affairs Specialist




Company Name:

Invivoscribe

Job Location:

San Diego, CA

Position Title:

Senior Regulatory Affairs Specialist

Position Type:

Full time

General Job Description


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.


Responsibilities:

  • 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.

Qualifications:


  • B.S. 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.


Application Information & Contact (How to Apply)


Apply here