Regulatory Specialist II
3 weeks ago
Job Title: Regulatory Specialist II
Duration: 12 Months (Possibility of extension)
Location: Lake forest, IL (60045) – Open for remote
Shift: 8 am – 5 pm
Pay Rate Starts from $52/hr on W2 (Negotiable for the right candidate)
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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