Recrutement Katalyst HealthCares Charlotte, NC

Recrutement Regulatory Affairs Specialist

Katalyst HealthCares & Life Sciences - Charlotte, NC

Responsibilities: The Regulatory Affairs Specialist is responsible for working with cross-functional teams to bring IVD (In-Vitro Diagnostic), Research (RUO) and Laboratorial products to market and support activities related to Quality Ma......

23 novembre 2025

Recrutement Sr.Clinical Data Manager

Katalyst HealthCares & Life Sciences - Charlotte, NC

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 timelin......

12 novembre 2025

Recrutement Regulatory Affairs Specialist

Katalyst HealthCares & Life Sciences - Charlotte, NC

Responsibilities: Preparing documentation for international regulatory registrations. Preparing technical documentation to compliant to MDD and EU MDR. Defining worldwide regulatory requirements are necessary for regulatory approval of ......

26 septembre 2025

Recrutement Clinical Data Manager

Katalyst HealthCares & Life Sciences - Charlotte, NC

Responsibilities: Act as Lead Data Manager, overseeing all deliverables of activities outsourced to DM CRO for multiple studies. Interact and manage relationships with other functional areas to ensure high quality data management activit......

26 septembre 2025

Recrutement Senior Clinical Data Manager

Katalyst HealthCares & Life Sciences - Charlotte, NC

Responsibilities: Represent Data Management in study team meetings, providing metrics and guidance on data-related issues. Oversee Data Management activities from study start-up to close-out. Develop and manage study timelines and ensur......

26 septembre 2025

Recrutement Senior Manager, Regulatory Affairs

Katalyst HealthCares & Life Sciences - Charlotte, NC

Responsibilities: The Senior Manager, Regulatory CMC Technical Writing and Submission Management role will be responsible for supporting the authoring, compiling and management of CMC sections for global regulatory filings. This role req......

26 septembre 2025

Recrutement Global Regulatory CMC Manager

Katalyst HealthCares & Life Sciences - Charlotte, NC

Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC submissio......

26 septembre 2025

Recrutement Supplier Quality Engineer

Katalyst HealthCares & Life Sciences - Charlotte, NC

Job Description: Suppliers Primary Evaluations, PCPA audits, Technical Sign-off, APQP Implementation, Risk assessment and mitigation plan signoff, Design review, Tool Kick off, Tool Development Tracking, Fixtures / gauges / Tools readiness......

26 septembre 2025

Recrutement Lead Clinical Data Manager

Katalyst HealthCares & Life Sciences - Charlotte, NC

Job Description: We are seeking a highly skilled Lead Clinical Data Manager to join our team on a contract basis. The ideal candidate will have extensive experience in Clinical Data Management (CDM) within the Medical Device or Pharmaceuti......

21 septembre 2025

Recrutement Clinical Programmer

Katalyst HealthCares & Life Sciences - Charlotte, NC

Responsibilities: Provide clinical programming expertise to support clinical trials, global filings, regulatory queries, data collection, and cleaning. Provide input from statistical programming to support clinical trials, global filings......

19 septembre 2025