Regulatory Affairs Associate

Role: Regulatory Affairs Associate

Location: Lake Forest, IL - 60045

Duration: 12 Months

Shift Timings: 8 am to 5 pm

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.

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