Medical Devices Engineer KATALYST HLS

Job Description:
Support new product design, development and implementation of delivery devices and Client injection tools/aids for biologic therapeutics.
Primary technologies include auto-injectors, patch infusers/pumps, and needle stick prevention devices utilizing pre-filled syringes and cartridges.
Execution of mechanical and analytical testing to support the selection, design verification, commercialization and marketing of various medical device designs.
This will include the execution of routine and ongoing R&D stability testing, design verification testing, complaint investigations and special testing requests.
Work with design engineers and the medical device development laboratory manager to identify, develop, implement, qualify and validate new testing equipment.


Medical Device Senior Regulatory Affairs Specialist KATALYST HLS

Job Description:
Provide leadership and submission strategy in the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies (directly or with customers) for Pharmaceutical/ Device Combination Products.
Collaborate with cross-functional team to support customer filing strategy and manage regulatory activities and timelines for investigational and commercialized products.
Lead and coordinate the timely compilation and critical review of the CMC data package from other functional team representatives to provide complete and appropriate documentation that supports agreed world-wide registration timelines.
Provide CMC regulatory guidance to project teams and Global Regulatory team.

Project Manager (Regulatory affairs, Medical devices) katalyst HLS

Primary Responsibilities and Duties:
Determine and communicate deliverables and deadlines to business unit core project teams to ensure accurate expectation setting/planning, such as any required documentation, sample types and quantities needed, expected completion dates for any deliverables. In cases of expedited requests, work with the necessary group managers to agree on accelerated timeline/strategy.
Work with toxicologists and group managers to ensure test plans are developed to meet project goals. Create, organize, and maintain hard copy testing project files and electronic database.
Monitor progress of upcoming and ongoing projects. Provide customers, and internal management with progress reports and/or status updates. Promptly identify issues or delays and work with affected personnel to resolve issues and communicate any changes in strategy or timelines.


Manufacturing Engineer,Medical Devices job – Katalyst HealthCares & Life Sciences – Raleigh, NC

March 2, 2018 – Manufacturing Engineer,Medical Devices – p b Job description: /b /p ul li This position is responsible for supporting process and system improvements in a high volume medical device


Medical Device Regulatory Consulting Services – Katalyst HLS

Medical Device Regulatory Services:
Pre-market approval – PMA.
Pre-market notification – PMN 510(k)
Investigational Device Exemption – IDE (for clinical studies)
Combination product (Drug/Device) Submissions
Establishment Registration and Device listing
Patent Registration
Strategy and Regulatory Agency meetings.


Regulatory Specialist, Medical Devices Katalyst HLS

Job Description
Job Description:
Ensure compliance to local regulations and policies.
Implement NPI & develop the regulatory submission plan. Support data analysis, mapping and migration activities from legacy systems
Oversee preparation and review registration documents to ensure the submissions meet appropriate standard and content requirement.
Interact with regulatory agency actively to expedite approval of pending application and to resolve regulatory matters.
Provide regulatory affairs support during internal & external audit.
Provide regulatory affairs support during internal & external audit.


Mechanical Engineer (Medical Device) Katalyst HLS

Job Description:
Bachelor’s degree in Mechanical Engineering or Biomedical Engineering.
5+ years’ experience in medical device related R&D.
Experience designing and testing mechanical systems.
Experience leading pre-clinical testing of devices and supporting clinical testing of devices.
Experience with hands-on prototyping, test methods/experiments, and data analyses.
Excellent interpersonal skills are required for satisfying internal customers (e.g. in supporting Marketing, Manufacturing Engineering, Quality).
Experience successfully utilizing CAD & analytical design to drive development such as Finite Element Analysis (FEA).