Regulatory Specialist II

4 weeks ago

Lake Forest, United States Spectraforce Technologies Full time
Position Title: Regulatory Specialist II
Location: Lake Forest, IL,60045
Duration: 12 months.
Shift Time: 8am - 5:00pm

Job Responsibilities:
  • 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.
  • 4+ years' experience in Regulatory Affairs role.
  • Strong knowledge of IVDR and EU regulatory requirements is required.
  • Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).
PREFERRED QUALIFICATIONS:
  • 1+ years' experience in an IVD or medical device manufacturing environment.

COMPETENCIES:
  • Good knowledge of EU and international regulations.
  • Demonstrated written and verbal communication skills.
  • Strong time management skills, with the ability to work on multiple projects
  • simultaneously. Ability to work independently as well as within a team.
  • ? Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio

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