Regulatory Affairs Specialist II

2 weeks ago

Lake Forest, United States DivIHN Integration, Inc Full time
*Title: Regulatory Affairs Specialist II *
Location: Lake Forest, IL
Duration: 12 Months

*A detailed description of the position will be shared once we get your application*

*Regulatory Affairs Specialist II *

*Description*
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 Client 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

Job Type: Contract

Pay: $42.00 - $56.50 per hour

Benefits:
* Dental insurance
* Health insurance
* Life insurance
* Referral program
Schedule:
* Monday to Friday

Application Question(s):
* Do you have a Bachelor’s Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience?
* Do you have 4+ years’ experience in Regulatory Affairs role?
* Strong knowledge of IVDR and EU regulatory requirements is required
* Do you have 1+ years’ experience in an IVD or medical device manufacturing environment.

Work Location: In person

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