· 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