- Merck (West Point, PA)
- …registration stability manufacturing by designing, developing and scaling-up the formulation, device , and manufacturing process. Driving drug product design from ... (ExDM) team within PSCS is focused on executing the our company Research Laboratories drug product and device sourcing strategy across all phases of small and… more
- Globus Medical, Inc. (Audubon, PA)
- …is a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, , preferably within orthopedic medical devices; + ... At Globus Medical , we move with a sense of urgency...and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III… more
- Merck (West Point, PA)
- …support of Autoinjectors. The ideal candidate will possess extensive knowledge in medical device engineering, particularly in the design, manufacturing, and ... a minimum of 20 years of hands-on experience in medical device engineering, with a focus on...Familiarity with materials science, particularly as it relates to drug delivery systems, including knowledge of damage mechanisms, common… 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 Pulmonology (Biotech)- Blue Bell, PA- REMOTE...and quality delivery of study objectives. + Collaborate with Drug Safety teams to assess Serious Adverse Events and… more
- Teleflex (Wayne, PA)
- …in compliance with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements ... compensation package for this position will also include benefits such as medical , prescription drug , dental and vision insurance, flexible spending accounts,… more
- Merck (West Point, PA)
- …**Required Skills and Experience:** + Subject matter expertise in packaging and/or medical device and combination product components as well as development ... Performance Indicators (KPI), Leading International Teams, Management Process, Manufacturing Scale-Up, Medical Device Regulations, Medical Devices, Packaging… 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
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …expertise in applying FDA design control requirements (21 CFR ) as applied to medical device software and medical device regulation (IEC-62304) ... be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical , dental, vision, prescription drug coverage, company provided basic life,… more
- Globus Medical, Inc. (Audubon, PA)
- …or equivalent work experience + 5+ years of related experience in the medical device industry + Understanding of regulatory requirements throughout the product ... At Globus Medical , we move with a sense of urgency...and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III… more
- Bausch + Lomb (Harrisburg, PA)
- …functional areas to provide input on study-related documents and issues (DMP, SAP, drug / device supplies, CSR, etc.). + Provides clinical operations input in the ... Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance/GPSS and Drug / Device Safety, and Clinical Supplies), and external consultants… more