- Bayer (Indianola, PA)
- …Agile methodology; + Prior internship experience in technical writing ability; + Knowledge of medical device regulatory processes. Employees can expect to be ... as applicable; + Ensure compliance with standard operating procedures for medical device development, including compliance with ISO 13485 and IEC 62304;… more
- Globus Medical, Inc. (Audubon, PA)
- …_functions._ Qualifications **:** + 3-7 years experience in mechanical design engineering; Medical device experience is strongly preferred + Bachelor's Degree in ... At Globus Medical , we move with a sense of urgency...compliance with Globus quality system and other applicable regulatory bodies. + Adheres to the letter and spirit… more
- Globus Medical, Inc. (Audubon, PA)
- …+ 1-3 years of mechanical design engineering experience preferably in the medical device field + Bachelor's degree in Mechanical Engineering required. ... At Globus Medical , we move with a sense of urgency...compliance with Globus quality system and other applicable regulatory bodies + Partnering with marketing and product managers… more
- Guidehouse (Philadelphia, PA)
- …Life Sciences practice is an engine of innovation, helping pharmaceutical, biotech, medical device , and diagnostic companies develop custom solutions that tackle ... value, access, pricing and commercialization strategy projects for pharmaceutical, biotechnology, medical device , and diagnostics companies. Our client services… more
- Veterans Affairs, Veterans Health Administration (Pittsburgh, PA)
- …Maintenance Management System (CMMS). Facilitates the project installation of both Medical Device Systems and Special Purpose Systems. Provides customer ... conduct pre-purchase evaluations and address pre-implementation security issues to ensure medical device isolation architecture requirements are met. They… more
- Organon & Co. (Plymouth Meeting, PA)
- …global GMP Quality Systems and regulatory requirements. + Experience in medical device Quality Systems is preferred, including familiarity with ISO13485, ... impact of products to Organon's revenue, number and complexity of in-markets, regulatory history, historical performance (production and compliance ), new product… more
- J&J Family of Companies (Allentown, PA)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... knowledge of clinical research, Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials. +...market releases. + Product knowledge including product vigilance and medical device reporting. + High attention to… more
- Globus Medical, Inc. (Audubon, PA)
- …following:** + Three to seven years' experience in mechanical design engineering; Medical device experience strongly preferred + Bachelor's Degree in Mechanical ... At Globus Medical , we move with a sense of urgency...compliance with Globus quality system and other applicable regulatory bodies + Designing and developing instruments and implants… more
- Fujifilm (Harrisburg, PA)
- …and advertising regulations and other regulations specific to Life Sciences/Pharma and Medical Device companies. + Perform other duties as assigned. **Required ... new business ventures. + Keep abreast of legislative and regulatory changes that may affect HLUS and its subsidiary...and/or in-house legal department, preferably in the Life Sciences/Pharma, Medical Device or health care field. +… more
- Cook Medical (Vandergrift, PA)
- …to achieve desired results in audit responses, quality system change tracking, and regulatory compliance analyses. - Attend, present and provide data for ... Physical Sciences, or related area.Minimum 3 years of experience working in a Medical Device or Life Sciences Quality Management System.Experience in quality… more