Regulatory Specialist

4 weeks ago


Scarborough, United States ProKatchers LLC Full time

Job Title: Regulatory Specialist

Location: 04074, Scarborough, Maine, United States

Duration: 06 Month


Job Description:

  • Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).
  • Provides regulatory support for diagnostic product development and commercial diagnostic products.
  • Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally.
  • Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments.
  • Researches and communicates scientific and regulatory information in order to write submission documents.
  • Compiles and publishes all material required for submissions, license renewals, and annual registrations.
  • Maintains approvals/licenses/authorizations for existing marketing authorizations.
  • Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations.
  • Develops internal procedures and tools.
  • Conducts informational or training sessions for stakeholders.
  • Organizes and maintains hard copy and electronic department files.
  • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

Basic Qualifications | Education:

  • Bachelor’s Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.

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