Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications.
Works under moderate guidance and is responsible for the coordination and preparation of document packages for regulatory submissions from all areas of the Company. Compiles materials required in submissions, license renewals and annual registrations.
Keeps abreast of regulatory procedures and changes.
Coordinates the collection of documents, records, reports and data from Development, Clinical Affairs, Quality and Operations Departments for inclusion in regulatory documents.
Helps with the preparation of submissions for FDA product approval including 510(k)s, PMAs, INDs, BLAs as assigned.
Assists in the review of product labeling/advertising to ensure compliance with federal regulations.
Assists in the preparation of international registration dossiers for use in international registration by Roche Diagnostic Affiliates.
Participates with internal/external teams and builds professional relationships.
Identifies and suggests solutions to Regulatory tasks.
Other duties as assigned by management.
Bachelor's Degree in a science, engineering, or related technical field; advanced degree preferred. Regulatory Affairs Certification preferred.
3 years experience in regulatory, development, clinical affairs, quality, or program management in IVD, medical device, or pharma industries.
Experience with regulatory submissions including IDE, 510(k), and PMA submissions is preferred.
5% travel based on business needs