The Program Manager will provide regulatory and quality support for product submissions, approvals, and launch readiness. You will work hand in hand with multi-functional teams and may provide individual contribution to meet the team’s objectives. You will be responsible for developing program timeli...
Regulatory Affairs Manager, UK-based, Global Medical Device Design and Manufacturing Company Please relate to the team the excellent job they have done on the IND reactivation. Specifically, the high-quality module 3, written by Freyr. It was very comprehensive, very few revisions were required, ...
As a Quality Assurance and Regulatory Affairs Manager, you will play a critical role in ensuring compliance with regulatory standards and maintaining the highest quality standards throughout our life science product manufacturing processes. You will be responsible for managing quality assurance programs and...
LuminLogic is a fully configurable medical device QMS and regulatory compliance software for complete product lifecycle development. Learn more here!
Sikich Regulatory, Quality & Compliance (RQ&C) is comprised of subject matter experts, consultants, technologists and care professionals that have the technical skills and domain knowledge to guide every step of digital transformation. Our experience in regulated industry landscapes allows us to truly ...
As a Regulatory Assurance Manager, you'll support and deliver high quality assurance reviews of the prudential regulatory reporting on a rotational risk-based coverage basis assuring the adequacy of the design and operational effectiveness. You'll run and undertake key aspects of the regulatory assuran...
Perform other duties as directed by RAQA manager. Who are we looking for: Bachelor's degree in medicine or Bioengineering or above preferred. Regulatory and quality assurance/auditor experiences in international company for more than 5 years. ...
5.Support and assist Quality Assurance Manager on product returns. 支持并协助QA经理处理产品退货。 6. Assist Director Quality& RA and QP on recall plans, collecting and handling the adverse reaction information. 协助质量&法规事务总监和质量受权人产品召回计划,并负责药品不良反应信息的收集和处理。
“This team has created a truly collaborative work environment where we have addressed multiple issues of which we were previously unaware. We’re excited about having a much leaner and more efficient system.” Sr. Manager, Regulatory Compliance ...
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and ...