Regulatory Affairs Specialist II

by | Sep 23, 2021 | Expired Jobs

Company Name:

Grifols Diagnostic Solutions Inc.

Job Location:

San Diego, CA

Position Title:

Regulatory Affairs Specialist II

Position Type:

Full time

Overview of Position

Regulatory Affairs Specialist 2 responsible for domestic and international regulatory activities associated with FDA, Notified Body in EU, and other international regulatory agencies. This position requires a person with commitment to excellence, and ability to work in a fast-paced, technically skilled, team setting.

Responsibilities:

  • Prepare, compile and publish electronic pre-market and post-market regulatory submissions for FDA (CBER) including IND, BLA, Prior Approval Supplement, CBE/CBE-30 supplement, annual Report and Type B/C Meeting Requests.
  • Compile Technical Files and Design Dossiers for IVD medical devices to support EU CE-Mark.
  • Interact with business partners to support ROW submissions for IVD medical devices (Asia PAC, Mexico, Brazil, Canada etc.).
  • Interact with FDA, write responses to information requests, compile complete response letters.
  • Participate in the preparation of 510(k), PMA and PMA Supplement submissions for FDA (CDRH).
  • Develop and execute submission strategies for assigned projects. Monitor progress on key project deliverables and provide status updates on regular basis.
  • Review of product labeling, literature and Web site for accuracy, consistency and regulatory compliance.
  • Develop and/or revise regulatory procedures.
  • Provide regulatory support to existing and new cross-functional product core teams.
  • Review new product design protocols related to verification and validation, risk assessment, etc. Education
  • Demonstrated ability to coordinate complex projects.
  • Strong oral and written communication and presentation skills
  • Solid working knowledge of the US Regulations and European IVD and medical device directives
  • Good analytical and problem solving skills.
  • Demonstrate in-depth understanding of advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
  • Experience with (US) Biologics and IVDs highly desirable.
  • Capacity to communicate regulations to technical functions within the company.
  • Ability to manage relationships with FDA and international customers (e.g., regulatory agencies, distributors, etc.)
  • Solid computer skills in Microsoft Office.

Qualifications:​

Bachelor’s Degree required in the life sciences or engineering with a minimum of 5-8 years direct experience in Regulatory Affairs within an IVD or Drug/Biologics Industry.

Master’s Degree and/or RAC preferred with a minimum of 3-5 years direct experience in Regulatory Affairs within an IVD or Drug/Biologics Industry. Experience

Application Information & Contact (How to Apply)

Please apply by visiting here

Learn more about Grifols here