Drug Safety Specialist job – Katalyst HealthCares & Life Sciences – South Plainfield, NJ

December 6, 2017 – Drug Safety Specialist – p b Responsibilities or Duties: /b /p ul li Management of individual case study reports (ICSRs). /li li Perform quality control activities to


Commercial Data Processing & Analytics job – Katalyst HealthCares & Life Sciences – Summit, NJ

December 6, 2017 – Commercial Data Processing & Analytics – p b Requirements: /b /p ul li Minimum 5 years of experience in governance and analytics of US commercial data e.g. Symphony, IMS, affiliations,

Senior Mechanical Engineer job – Katalyst HealthCares & Life Sciences – Detroit, MI

December 5, 2017 – Senior Mechanical Engineer – p b Description: /b /p ul li Participates in a development team under the instruction and direction of a more senior engineer. Assist in the

Senior Manager for Global Risk Management job – Katalyst HealthCares & Life Sciences – Summit, NJ

December 4, 2017 – Senior Manager for Global Risk Management – p b Job description: /b /p ul li Preparing and updating risk management plans (e.g. REMS, EU-RMPs) for product submissions including NDA and

Post-Market Quality Engineer, Exton, PA – Katalyst HLS

The Post-Market Quality Engineer (QE) will provide technical quality leadership and support for on-market medical device and combination products.

This Post-Market QE will:
Work collaboratively with internal Quality and cross-functional colleagues to ensure medical devices and combination products comply with FDA 21 CFR requirements and international standards (e.g., ISO, AAMI, ANSI), specifically supporting:
– Transition ISO 13485 certification and product licenses between locations / entities due to pending closure of Westlake Village facility
– Establishment of harmonized processes to meet new ISO 13485 and MDR requirements expected to be implemented in 2018
– Internal / external inspections and notified body interactions related to transition and new regulations
– Supplier quality related activities during transition of responsibilities from SQM to Device Quality

Lead Clinical Trial Assistant job – Katalyst HealthCares & Life Sciences – Carlsbad, CA

November 28, 2017 – Lead Clinical Trial Assistant – p b Position Description: /b /p ul li The Lead Clinical Trial Assistant (CTA) in collaboration with the Clinical Trial Manager, contributes to

Junior Technical Support (Quality Engineer – Medical Device) job – Katalyst HealthCares & Life Sciences – Princeton, NJ

November 27, 2017 – Junior Technical Support (Quality Engineer – Medical Device) – p b Responsibilities : /b /p ul li Provide technical support for Class I and Class II medical devices. /li li Evaluate returned electronic