CytoSorbents Corporation (CTSO)

[Good Sport]

Very good sign imo...
They are gearing up ! Job just posted 1 day ago:

Regulatory Affairs Manager - PMA Submission
Fully Remote • Princeton, NJ

Description
CytoSorbents, a critical care leader specializing in blood purification and blood products technologies to treat critically ill, injured, and surgical patients, is seeking a Regulatory Affairs Manager who is experienced in authoring PMA submission(s).



The Regulatory Affairs Manager contributes to regulatory submission strategy, identifying submission risks and opportunities, while managing regulatory applications through approval. Provides regulatory expertise and guidance on procedural and documentation requirements. Is fully proficient in applying established standards. May facilitate strategic input. Participates in continuous improvement of process and tools/systems.



Come join us in saving lives!



Responsibilities:

Participating in writing, compiling, and publishing of PMA regulatory submissions.
Manages information pertinent to the regulatory process. Maintains Regulatory Affairs product files (design dossiers, periodic regulatory reports) to support compliance with applicable regulatory requirements.
Provide regulatory input to cross-functional teams.
Assists with the research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
Keeps management informed of regulatory requirements and emerging issues which may affect the registration approval of products.
Supports, and participates in the development of product labeling, evaluation of promotion and advertising material for compliance with applicable regulations, and reviews of proposed product changes for impact on regulatory status.
Provides training and guidance to entry-level associates, interns, specialists, and project managers.
May communicate with Regulatory/Governmental agencies Miscellaneous responsibilities as assigned.
Writes and reviews SOPs as required to ensure compliance with applicable regulatory requirements.
Assists in regulatory audits and inspections.
Develop plans to meet pre-defined Regulatory goals.
Remote with occasional onsite visits.
Requirements
Bachelor’s degree in life sciences, engineering or related field. Advanced degree strong preferred.
5+ years of experience in Medical Device Regulatory Affairs, including preparation of PMA submission(s) to the FDA/EU.
Experience authoring at least one Premarket Approval (PMA) application and submission to the FDA.
Demonstrated the ability to complete internal update (letters to file) independently.
Regulatory Affairs Certification (US / EU) preferred.
https://recruiting.paylocity.com/recruiting/jobs/Details/1854410/Cytosorbents-Medical-Inc/Regulatory-Affairs-Manager---PMA-Submission?source=Indeed_Feed