Regulatory Specialist II

2 weeks ago

Lake Forest, United States Spectraforce Technologies Full time
Job Title: Regulatory Specialist II
Duration: 12 Months (Possibility of extension)
Location: Lake forest, IL (60045) - Open for remote
Shift: 8 am - 5 pm

Summary:
The position of Regulatory Affairs Specialist II is within our Infectious Disease business unit. In this role you will prepare documentation for EU Technical Files and international product registrations.

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 companies 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.

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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