- Globus Medical, Inc. (Audubon, PA)
- …lives as quickly as possible. **Position Summary:** As a Group Manager of Software , you will be responsible for planning, managing and implementing all aspects of ... a software activities of a small software team... craftsmanship, and test-driven development. + Understanding of an FDA design control environment. + Supports manufacturing, internal testing,… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- **Job Description** We're looking for a Principal Software Engineer to join our growing team and lead the development and strategy for our Digital Medicine ... high-performance, scalable, data-centric, serverless microservices + Own and deliver software architecture, diagrams, design documents + Primary engineering lead,… more
- RELX INC (Horsham, PA)
- Director of Research and Software Engineering for Life Sciences Are you ready for a leading role? Would you enjoy working on our cutting-edge products? About Us At ... concepts. About the Role The Director of Research & Software Engineering will lead the development of our regulated...ensures compliance with industry regulations (such as GxP and FDA 21 CFR Part 11), oversees daily operations, drives… more
- Eliassen Group (Harrisburg, PA)
- ** Software Engineer** **Anywhere** **Type:** Contract-to-Hire **Category:** Development **Industry:** Life Sciences **Workplace Type:** Remote **Reference ID:** JN ... Jobs **Description:** Our client is hiring for an iOS Software Engineer to join their team in San Diego,...PLUS: Bluetooth experience & Any industry experience that has FDA requirements OR enterprise level company experience and documentation.… more
- Sumitomo Pharma (Harrisburg, PA)
- …including computer word processing, electronic document management systems, and regulatory publishing software . + Robust understanding of FDA and other health ... + Distributing, and archiving all incoming and outgoing communications with FDA and international counterpart agencies. + Understands evolving Health Authority (HA)… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …and literature reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per ISO13485, ... as requested. The ability to maintain quality documents to ensure compliance with FDA regulations and guidance documents relating to these areas of responsibility is… more
- Guthrie (Sayre, PA)
- …direct experience in clinical or pharmaceutical-sponsored research or regulatory fields such as the FDA , NIH, or HHS. + Minimum 5 years of experience in managing a ... Operations & Compliance + Deep understanding of human-subjects research compliance (AAHRPP, FDA , IRB, GCP, ICH). + Experience in integrating clinical research into… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …+ Prepare, submit and coordinate the process validation requirements for non-product software validations + Participates in the FDA premarket approval process ... that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …investigation and Regulatory Affairs for arranging more information/ samples from FDA . + Managing Quality Management Review meetings, circulating minutes of meeting, ... Product Recalls, making sure no delay in submission to FDA per defined timeline. After initial submission, keeping track...new starters & refresher trainings etc. Handling of training software . + Ensuring DSCSA compliance is maintained for Rx… more
- Globus Medical, Inc. (Audubon, PA)
- …prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. The ... product development + Creates and maintains project plans and FDA complaint Design history Files (DHF) for each project...and develops instruments and implants using Creo and SolidWorks software + Partners with in-house prototype shop and outside… more