Regulatory Affairs Specialist I - Katalyst Healthcares & Life Sciences
San Diego, CA 92101
About the Job
Responsibilities:
- 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.
- Research 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.
- 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.
Source : Katalyst Healthcares & Life Sciences