cGxPServe

Job Description: We are seeking an experienced MES Functional Consultant with strong manufacturing process knowledge and expertise in requirement gathering for MES system implementation. The role will require excellent requirement gathering skills to capture both business and technica المزيد...

Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe support of international product registrations and related regulatory affairs activities including execution of procedures and s المزيد...

Job description: The C&Q Engineer is responsible for the execution of the defined C&Q scope of the following areas Black Utilities and HVAC. These are Client-side roles and key responsibilities are meeting the agreed objectives regarding time schedule and functionality according المزيد...

Responsibilities: The CSV Lead manages quality control checks on engineering project work. The CSV Lead will have 10 plus years of experience of automation systems computer systems validation in a GMP environment. The CSV Lead will be responsible to assist Client in designing the val المزيد...

Responsibilities: Create or review and approve programming plans at study and project level. Provide input on key study-related documents produced by other functions (e.g. CRFs Data Management Plan SAPs etc.) Create or review and approve CDISC-compliant datasets and corresponding doc المزيد...

Responsibilities: This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. Manage new 3rd party supplier documentation strategy for peritoneal dialysis disposable sets. Manage chan المزيد...

Responsibilities: The Sr. Statistical Programmer supports the Biostatistics team in the generation and validation of analysis datasets and statistical outputs for clinical trials. This role is key to implementing programming standards and supporting the standardization of CDISC-compl المزيد...

Job Description: The Med Reviewer has a key role within the designated Therapeutic Area. Working under the leadership of the Scientific Director/Medical Director this leader supports the development and execution of the therapeutic area medical strategy specifically as it pertains to المزيد...

Responsibilities: Accurately document all testing activities maintain detailed data records manually and electronically and ensure compliance with documentation standards. Follow Good Laboratory Practices (GLP) and safety protocols to maintain a clean organized and safe working envir المزيد...

Responsibilities: Maintain study-specific documentation including Data Management Plans eCRF specifications and other related documents. Interact effectively with sponsors and oversee vendors. Develop SOPs and study-specific procedures. Manage Data Management tasks from study start-u المزيد...

Responsibilities: Develop implement and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA ISO 13485 IEC 62304) and industry best practices for non-product software. Support audits a المزيد...

Responsibilities: Lead end-to-end NPI activities for embedded software testing in medical devices. Oversee Test protocols test strategy and test automation testing aligned with IEC 62304 standards. Manage and troubleshoot communication protocols including BLE Serial SPI UART. Utilize المزيد...

Responsibilities: Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure high-quality within timeline and budget. Conduct hands-on validation/QC of CRO deliverables to ensure high-quali المزيد...

Responsibilities: Select and evaluate suppliers by leading efforts to find new suppliers in an existing or new commodity. Conduct on-site supplier assessments as well as QMS audits and address the non-conformities. Work with suppliers and ISI engineering for the new product introduct المزيد...

Responsibilities: To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required) and to ensure timely and accurate programming and validation activities for clinical studies and publications. Contribut المزيد...

Responsibilities: Develop global regulatory strategies for medical device products to meet business objectives and collaborate across a matrixed organization to ensure global success of products registration. Participate on product development teams providing regulatory strategies ti المزيد...

Responsibilities: Autonomously support new product development core teams including development of regulatory strategies and the preparation of regulatory content for domestic and international submissions for IVD medical devices to support the core teams approved scope of regulatory المزيد...

Responsibilities: Responsible for the study-specific data management tasks from protocol review to database lock to ensure data are collected reviewed and delivered with high quality on-time and within scope. Responsible for the accurate development of CRFs and edit specification per المزيد...

Responsibilities: Manufacturing Engineer GMP FDA KPI ISO Standards Six Sigma Lean Methodology Risk management Validation processes Manufacturing Automation. Lead manufacturing programs to drive process improvements cost reductions and quality enhancements. Collaborate with R&D Qualit المزيد...

Responsibilities: The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS) Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products including regulatory responsibilities in associated change control an المزيد...