•   Full Time
  •   CA

Regulatory Affairs Specialist

Would you like to work for an innovative company? If so, come join our team!

Description of Position Responsibilities:

  • Prepare hardcopy and electronic information packages for submission to regulatory agencies.
  • Participate on product development core teams as regulatory representative.
  • Create regulatory strategies for domestic and international markets.
  • Monitor and receive deliverables for submissions.
  • Write and/or edit submission documents using regulatory templates.
  • Assemble paper and/or electronic copies for submission.
  • Assess manufacturing process and labeling changes for regulatory reporting impact.
  • Keep informed of new and revised regulations; disseminate information as directed by management.
  • Interact with regulatory agencies.
  • Prepare internal procedures for continuous process improvement.

Excellent Salary

Benefits include:
401k, Stock Options, Medical / Dental Insurance, Vacation and Sick Time.

Related Business / Technical Skills, Knowledge, Abilities:

  • Solid computer skills.
  • Solid written and oral communication.
  • In vitro diagnostics submission experience, US and International.

Education and Experience Requirements:

  • Typically requires a BS / BA degree or equivalent and a minimum of 2 – 5 years related experience or MS degree or equivalent and 1 – 3 years related experience.

For immediate consideration, please forward a copy of your current resume to referencing job # or a link to this job.

Job & Company Detail

Company Industry

Architect Industry

Company Size

1 - 9 Employees



Job Category

Manufacturing / Operations

Applications Accepted Until

01 January 2030