- 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
- Globus Medical, Inc. (Audubon, PA)
- …work experience + 5+ years of related experience in the medical device industry + Understanding of regulatory requirements throughout the product lifecycle + ... At Globus Medical , we move with a sense of urgency...as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains… more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of ... projects and issues affecting development of new products or medical devices or new indications for existing products +...years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the… more
- Olympus Corporation of the Americas (Center Valley, PA)
- … & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs , Research & Development, Legal, and Health Care ... Medical Safety, risk management Vigilance or other Medical Device Experience ( Medical ...local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Medical Affairs… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …strategies for the Digital/AI business units. + Drive cross-functional alignment between R&D, Regulatory , Medical Affairs , and Market Access teams. + ... and Marketing, R&D, PMO, HEMA, Risk Management, Quality and Regulatory Affairs , and investigational sites. + Ensure...systems. + Minimum of 15 years medical device industry experience post-degree in Clinical Affairs /Operations… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …to meet regulatory / procedural deadlines. + Demonstrated working knowledge of Medical Device Quality Systems regulations including ISO 13485, 21CFR820, and ... (https://www.olympusamerica.com/careers) . **Job Description** Responsible for the review of medical device global complaints and coordinate the resolution… more
- Teleflex (Wayne, PA)
- …with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ... expertise in management of prostate cancer. As a senior member of the Teleflex Medical Affairs team within Clinical and Medical Affairs (CMA) across… more
- Bausch + Lomb (Harrisburg, PA)
- …Management, Clinical/ Medical Affairs , Biometrics, Regulatory Affairs , Quality Assurance, Pharmacovigilance/GPSS and Drug/ Device Safety, and Clinical ... in an accurate and timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house team of CRAs, CTAs… more
- University of Pennsylvania (Philadelphia, PA)
- …follow-up activities, performing phlebotomy to collect samples from patients, abstracting medical and demographics data from medical records, completing source ... managing the adverse event reporting process and assisting with the regulatory and financial management of multiple studies. Coordinate several investigational … more
- ICON Clinical Research (Blue Bell, PA)
- …we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With ... Medical Director** specializing in **Pulmonology** to join our global Biotech Medical Affairs team. Working in a fast-paced, client-focused global… more