Regulatory Affairs Specialist II

·         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.   

·         This job description will be reviewed periodically and is subject to change by management.

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 our 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 MS Office, including Word, Excel, PowerPoint and Visio