cGxPServe

Job Description: Seeking a Regulatory Affairs Associate to support international addendum labelling (IFUs import labels and country-specific labeling) for medical devices. This role involves collaboration with global RA teams and ownership of labeling compliance processes. Responsibil More...

Responsibilities: Provide QA oversight of CQV activities for the cGMP manufacturing facility and quality control laboratories. Provide QA oversight for periodic review and requalification program. Perform review of CMMS records related to asset management including asset release data More...

Job Description: Perform SCF operations maintaining product quality and production levels. Work as member of a team for maximum effectiveness. Responsibilities include product inspection operating equipment raw material/finished goods movement and cleaning/sanitizing. Monitor machine More...

Job Description: The Quality Assurance team within the Worldwide Operations Manufacturing department is seeking an enthusiastic results-oriented and experienced Quality Assurance Specialist to join our organization as a Remote Worker. The candidate will be responsible for supporting More...

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 More...

Responsibilities: Provide leadership strategic planning direction and implementation of clinical systems for data collection which may include vendor selection budgeting resource planning vendor oversight EDC build and study timelines etc. Perform or provide oversight to staff for al More...

Responsibilities: Preparing documentation for international regulatory registrations. Preparing technical documentation compliant to MDD and EU MDR. Defining worldwide regulatory requirements necessary for regulatory approval of products. Participating on cross functional teams as re More...

Responsibilities: Assist in the development testing and validation of Electronic Data Capture (EDC) systems and Case Report Forms (CRFs). Support database setup activities including edit check specifications and user acceptance testing (UAT). Review incoming clinical data for complet More...

Responsibilities: Regulatory / V&V / Quality Assurance Engineer with 10-14 Years of experience. Knowledge of Design History file Device History Record and Device Master Record documents. Proficiency in Project management and execution. 3-6 years of experience in DHF gap analysis / re More...

Job Description: Our client is currently building (started in 2024) a 125000 sq ft greenfield manufacturing facility outside of Pittsburgh PA. Expected to be operational by 2027 Q1. The electricity gets turned on in this facility in the end of Jan 2026. The facility will be state of More...

Requirements: Review and support design verification protocols and test reports. Ensure compliance with internal design verification design control equipment control and risk management procedures. Assist cross-functional teams to complete design verification activities on time. Guid More...

Responsibilities: Lead the creation of the Data Review and Cleaning Plan and development of the data cleaning strategy. Provide oversight of the data validation plan and provide DM insight to maximize the data validation strategy. Review CRFs to ensure alignment with protocol; lead a More...

Responsibilities: Design code and test SAS programs used to generate CDISC SDTM & ADaM domains and tables listings & figures outputs. Perform analyses defined in the statistical analysis plan as well as ad hoc analyses as requested. Validate CDISC SDTM and ADaM data sets by using Ope More...

Job Description: This section focuses on the main purpose of the job in one to four sentences. Technical lead for DHF structure within sustaining engineering for disposable medical devices. Responsibilities: This section contains a list of primary responsibilities of this role that a More...

Responsibilities: Responsible for the oversight of all data management CRO activities supporting companys clinical programs from database start-up through database lock and CSR/submission. Serves as primary point of contact with the DM CROs 3rd party vendors and internal study More...

Responsibilities: Create new 3rd party supplier documentation including design specifications labeling design drawings etc. for peritoneal dialysis disposable sets. Create modify and maintain design history files. Perform change control assessments. Work closely with project manager More...

Responsibilities: Hands-on statistical programming to support CSR publications presentations DSUR IB update safety data review reconciliation ad hoc analyses patient profiles and monthly safety reports in a fast-paced environment. Write or review data specifications for Study Data Ta More...

Responsibilities: Demonstrating proficiency in CDISC SDTM and ADaM to support various submission activities including IA CSR DSUR and publications. Providing statistical programming support to generate tables listings and figures for assigned projects. Overseeing all aspects of stati More...

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 More...

Job Description: We are seeking a Cleaning Validation Engineer with hands-on experience in the startup and validation of clean utility systems such as Water Generation Systems (WFI/RO/DI) Clean Steam Systems Process Gas/Air Systems Distribution Systems Storage Tanks and CIP/COP System More...