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.

Skills: Knowledge of regulations and standards affecting IVDs and/or biologics

Duties:
Responsible for implementing and maintaining the effectiveness of the quality system.
Supports manufacturing/operations day to day activities for change control.
Provides consultation/advice to regulatory specialist for change control and product development. Provides regulatory direction/interpretation on team activities.
Interprets and applies regulatory understanding to support of products and teams.
Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
Handles regulatory activities involved in documentation, labeling, field support.
Applies regulatory and technical knowledge to a wide variety of complex work assignments. Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

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 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 microbiology, immunology, medical technology, 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.
2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function

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