at Manpower Group in Lake Forest, Illinois, United States
Job Description
Experis IT ManpowerGroup has partnered with a leading Medical Device Co in the Lake Forest IL area for a Regulatory Specialist II role to assist their team. This is an Onsite role.
Industry: Medical Device Co
Title: Regulatory Specialist II
Location: ONSITE – Lake Forest IL
Duration: 12 months
Shift: M-F 8 am – 5 pm
Pay: $41 per hour.
Job Description
+ This role will provide compliance support to the Regulatory Affairs organization by -
+ Responsible for technical writing of files by In Vitro Diagnostic Medicaldevice Regulation (IVDR).
+ Provides regulatory support for diagnostic product development and commercialdiagnostic products.
+ Develop regulatory strategies for products in development and for modified products toachieve 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 to writesubmission documents.
+ Compiles and publishes all material required for submissions, license renewals, andannual registrations.
+ Maintains approvals/licenses/authorizations for existing marketing authorizations.
+ Assesses product, manufacturing, and labeling changes for regulatory reporting impactand compliance with regulations.
+ Develop 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
+ Abbott Quality Management System per ISO, FDA, and other regulatory agencies.
You will need to have:
+ Bachelor’s Degree in Biology, Chemistry, Biochemistry, Engineering or other relatedtechnical 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
ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee’s race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.
