Regulatory Affairs Specialist II

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

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