Valuesoft Info - Regulatory Affairs Role

Description

Responsibilities:

- Support the regulatory activities needed to comply with the European In Vitro Diagnostic Regulation (IVDR 2017/746) by performing the following:

- Regulatory review of technical documentation for reagents, calibrators, controls, and other in vitro diagnostic products to comply with European In Vitro Diagnostic Regulation (2017/746/EU).

- Identify and close gaps in technical documentation.

- Work collaboratively to complete tasks, both within regulatory affairs and with other departments.

- Maintain technical documentation for in vitro diagnostic products in compliance with European

- In Vitro Diagnostics Directive 98/79/EC (IVDD) or creation of technical documentation compliant to IVDR.

- Create, review, and route for approval EU Declarations of Conformity.

- Provide regulatory review of the claims and technical files to maintain EU CE marking under IVDD.

- Provide periodic progress reports to supervisors.

- Attend in-person and teleconference meetings as assigned.

- Prepare finished IVDR technical documentation for submission to the Notified Body.

- Prepare quality records for electronic archival.

Must Have:

- Education: Bachelor of Science / Engineering in a Science related field.

- Quality or Regulatory Affairs Experience (3-6 yrs) in an industry such as pharmaceuticals, medical devices, or in vitro diagnostics.

- Experienced in Reviewing Technical Documentation

- Proficiency with Windows 10 and Microsoft Office 365.

- Proficiency with Windows and Microsoft Office.

Preferred Skillsets:

- Experience with and knowledge of (a) the European In Vitro Diagnostics Medical Devices Directive (IVDD 98/79/EC) and/or (b) the European In Vitro Diagnostic Regulation (IVDR 2017/746).

- Experienced Working with Cross Functional Teams

- Experience with SAP.