. Join us and help shape wherever we go next. You create your future and ours. As a Senior Regulatory Affairs Specialist you play..., creativity, and collaboration. Senior Regulatory Affairs Specialist working independently, is responsible for fulfilling...
company’s success. As a Risk and Control Specialist Senior within PNC's Regulatory Affairs organization, you will be based in... Specialist Senior, you will be responsible for managing and coordinating the regulatory exam lifecycle, which includes pre-exam...
. The Regulatory Affairs Specialist will work closely with the Director of Regulatory Affairs to obtain and maintain global... its mission. Job Summary: The ideal candidate is a diligent, hardworking individual with 2 to 5 years of regulatory experience...
The Sr. CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved... and planned clinical regulatory landscape by contributing to the regulatory submission form process. A typical day might include...
Industry/Sector Asset and Wealth Management Specialism Assurance Management Level Senior Manager... Job Description & Summary A career in our Regulatory Strategy and Governance practice, within Regulatory Risk and Compliance services...
more than 130 million patients annually. More information is available at . We are currently seeking an Senior Regulatory.... What you will do As part of the Medical Regulatory Affairs team, you will work with the team to maintain medical devices on the market...
OF DUTIES Responsible for coordinating, preparing, and maintaining regulatory submissions and documents on a global level... for Europe, the United States, and other countries. Primary responsibilities are to ensure regulatory compliance for assigned...
Responsibilities: Serve as the senior and principal regulatory affairs member of project development teams, primarily... focused on (but not limited to) drug products. Provide regulatory oversight and guidance to project teams on compliance...
Meridian’s regulatory and quality system processes, specifically as it relates to the product realization process for SD... Biosensor products to ensure that activities are consistent with applicable quality and regulatory requirements, especially the...
of additional clinical oversight and support from a compliance and regulatory perspective. Essential Functions * Delegates... specific clinical tasks to community care staff guided and as required by the State Board of Nursing and the State Regulatory...
with applicable regulatory requirements and expectations (GXP, GAMP5, 21 CFR Part 11 (US) and EU Annex 11). This role... for implementation of site procedures regarding validation requirements for e-systems to ensure they comply with regulatory requirements...
regulatory management systems activities, including systems coordination, training others, developing and implementing plans.... Required Knowledge and Experience: Requires a Baccalaureate degree Minimum of 4 years of regulatory affairs experience or advanced...
Responsibilities: As a regulatory process expert supporting global registrations the candidate interprets federal..., devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems...
. RESPONSIBILITY AND AUTHORITY The primary responsibility of this position involves the preparation of regulatory submissions (510... standards, as well as handling corrective actions. May assist in the performance of internal quality and regulatory compliance...
Information Services department, this position will work with the global quality organization and regulatory teams to ensure..., biology or any related science required, masters preferred 3-5 years experience food regulatory experience...
division and become a member of a large and experienced regulatory team! Learn more about our Urology division here: https.../regulatory pathway development, testing requirements, clarifications, responses to questions/inquiries, and follow-up...
division and become a member of a large and experienced regulatory team! Learn more about our Urology division here: https.../regulatory pathway development, testing requirements, clarifications, responses to questions/inquiries, and follow-up...
. Requirements: MUST HAVE 4+ years of Regulatory experience in the IVD space. Previous experience with 510k submissions...
Responsibilities: Compile, prepare, and review regulatory submission to US and EU. Anticipate regulatory obstacles... and emerging issues throughout the product submission. cycle and develop solutions with other members of regulatory and related...
Responsibilities and Requirements: Handling data management and retrieval of regulatory documents. Preparing... and submitting US regulatory filings on time and in compliance. Staying current with regulations and providing expertise in...