Regulatory Affairs Specialist I

This position will have direct responsibility for review and approval of labeling and advertising/promotional materials, approval of global product distribution, and maintenance of regulatory records and files. Provides regulatory support for diagnostic product development and commercial products, ensuring compliance with US, EU, and international regulations and standards. Reviews and approves labeling, advertising, and promotional materials, and manages translations for country registrations. Assists in developing regulatory strategies for new and modified products to achieve clearance/approval. Researches scientific and regulatory information to develop labeling requirements and reviews verification/validation and risk management reports for accuracy. Assesses product, manufacturing, and labeling changes for regulatory impact and compliance. Develops internal procedures and tools, and conducts informational or training sessions for stakeholders. Responsibilities

Same as above, emphasizing review and approval duties, regulatory support, and development of strategies and procedures. Requirements:

Bachelor's degree (BS/BA) in any biological science or technical degree. 2+ years' experience in Regulatory Affairs with 1-3 years of progressively responsible positions. Organizes and maintains department files and keeps informed of global regulatory information. Demonstrates commitment to the Company Quality Management System per ISO, FDA, and other regulatory agencies. Exhibits professional behaviour with internal/external business associates, reflecting positively on the company. Understands the quality consequences of improper job performance and is aware of potential device defects in their area of responsibility. Seniority level

Associate Employment type

Contract Job function

Legal Industries

Pharmaceutical Manufacturing #J-18808-Ljbffr