- Penn Medicine (Philadelphia, PA)
- …(CE) team, providing Clinical Engineering guidance around the implementation of medical devices and managing our Medical Device Cyber Security program. ... of healthcare. That involves interacting with clinicians, educators, networking, MDS (interfacing medical devices with other systems), regulatory , safety,… more
- Merck (West Point, PA)
- …complex technical projects and/or equipment technology assessments within the packaging and Medical Devices & Combination Products (MDCP) space as part of ... and Qualifications:** + Minimum of 10 years' experience in the pharmaceutical, biotechnology, or medical device industry, with at least 3-5 years in a leadership… more
- Cook Medical (Vandergrift, PA)
- …Physical Sciences, or related area.Minimum 3 years of experience working in a Medical Device or Life Sciences Quality Management System.Experience in ... - Collaborate with other departments to achieve desired results in audit responses, quality system change tracking, and regulatory compliance analyses. - Attend,… more
- Teleflex (Wyomissing, PA)
- …processes, regulatory requirements (eg, ISO 13485 and FDA 21 CFR 820) and quality standards for medical devices . * Understanding of design verification ... labs. You'll work closely with cross-functional teams including manufacturing, quality , and regulatory to bring innovative catheter...3 years of previous experience in related field (eg medical device design and manufacturing, or similar… more
- PCI Pharma Services (Philadelphia, PA)
- … quality management systems and regulatory requirements (FDA, ISO 13485, Medical Device Directive) + Strong knowledge of cGMP and other applicable ... requiring systemic solutions + Ensure compliance with FDA regulations, ISO 13485, Medical Device Directive, and other applicable standards and regulations… more
- Merck (West Point, PA)
- …risk, generate gap analysis and mitigation strategies + In-depth knowledge of global regulatory requirements for medical devices and combination products and ... Leading International Teams, Management Process, Manufacturing Scale-Up, Medical Device Regulations, Medical Devices , Packaging Engineering, Packaging… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …13485, IVDR, cGMP's, FDA Guidelines, USP, and GxP. + Detailed knowledge of medical device manufacturing processes and experience with risk management regulations ... to develop, modify, improve, and implement IT systems for the Quality and Regulatory Organization. + Develop policies and procedures supporting IT Systems used… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …control). + Minimum of 2 years Medical Safety, risk management Vigilance or other Medical Device Experience ( Medical Device preferred to Pharma) OR ... Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs, Research &...Progressive leadership experience in the health care setting. + Medical Safety ( Medical Device preferred… more
- Envista Holdings Corporation (Quakertown, PA)
- …regulatory and quality backgrounds that work collaboratively in the fast-paced medical device field. A friendly and open atmosphere helps to foster strong ... Up to 10%, as needed. **PREFERRED QUALIFICATIONS:** + MS degree preferred. + Medical device design and compliance experience. + Compliance Engineering: +… more
- Globus Medical, Inc. (Audubon, PA)
- …0-3 years of experience in product development or sustaining engineering within the medical device industry. + Proficiency with **CAD software (CREO or ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...Internship or co-op experience in a regulated industry, ideally medical devices . + Exposure to post-market surveillance… more