Regulatory Affairs Specialist I

20h20 hours ago

Werfen

Waukesha, US · Full-time · $72,000 – $92,000

About this role

Werfen is a worldwide leader in specialized diagnostics across Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. The Regulatory Affairs Specialist I manages worldwide registration, renewal, and compliance activities for Werfen-labeled products in these diagnostic areas.

Daily work centers on creating correction and removal files, authoring FDA MDRs and Health Canada MPRs, and supporting vigilance reporting through international offices. The role also includes maintaining regulatory records and the SAP database to ensure ongoing compliance.

This position participates on design and risk management teams for both Hemostasis and Critical Care product lines. Responsibilities extend to preparing registration packages, technical files, and renewal submissions while providing regulatory guidance on domestic and international requirements.

The specialist reviews labeling, change orders, and marketing materials prior to management signature. Additional duties involve technical review of data for submissions and identification of historical records suitable for future regulatory filings.

Requirements

Superior communication skills (verbal and written)
Knowledge of FDA, Health Canada, and international medical device regulations
Experience authoring regulatory submissions, technical files, and vigilance reports
Familiarity with 510(k), CE Mark, and country registration processes
Ability to participate on design and risk management teams as regulatory representative
Proficiency with SAP or similar regulatory databases
Skill in technical review of data for scientific rigor and regulatory compliance

Responsibilities

Create correction and removal files and author field communications with management review prior to submission.
Author FDA MDRs and Health Canada MPRs, reviewing contents with appropriate groups prior to submission.
Support worldwide vigilance reporting through international European regulatory offices while maintaining compliance records.
Participate on design and risk management teams as the regulatory representative and provide guidance on domestic and international requirements.
Assist with new product registration packages and technical files including CE Mark, 510(k), and Canadian licenses.
Prepare and maintain Technical Files to ensure ongoing regulatory compliance.
Review marketing promotional materials and labeling for management signature.
Maintain the Regulatory Database in SAP and perform other regulatory assignments to support company priorities.