- CSL Behring (King Of Prussia, PA)
- …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA ... and approval in one key region (EU, US, Japan) -Experience working in Regulatory Affairs with agency interaction responsibility with at least 1 health… more
- CSL Behring (King Of Prussia, PA)
- … regulatory outcomes.** **-** **Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling ... meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, Hematology ? The...key region (EU, US, Japan)** **-** **Experience working in Regulatory Affairs with agency interaction responsibility with… more
- CSL Behring (King Of Prussia, PA)
- …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA ... meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead? The job is...one key region (EU, US, Japan) -Experience working in Regulatory Affairs with agency interaction responsibility with… more
- CSL Behring (King Of Prussia, PA)
- …of 6 years of experience in the life sciences industry, with exposure to regulatory affairs or a related function. -Strong analytical, data interpretation, and ... developing therapies that make a meaningful difference worldwide. Could you be our next Senior Manager , Regulatory Science? The job is in our King of Prussia, PA… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …teams across Quality Management, Design Assurance, Research and Development, Marketing, Regulatory Affairs , Medical Safety, and within the broader Olympus ... Cochrane). + Close collaboration with Product Management, Risk Management, R&D and Regulatory Affairs to provide input on deliverables, clinical research and… more
- Parexel (Harrisburg, PA)
- …colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs (GRA), IT, etc.) is fully informed and ... **_Parexel FSP has an exciting opportunity for a Clinical Quality Operations Manager ! This is a remote role !_** **Position Purpose:** The Clinical Quality… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs , Research & Development, Legal, and Health ... + Various standards (GCP, ISO 13485, ISO 14971) + Regulatory filings (FDA IDE, 510K, EU-MDR CERs, SSCP, PMCFs,...ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.**… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA) ... The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per...initiates new or special assignments with occasional direction from Manager . Must have ability to work in a team… more
- Globus Medical, Inc. (Audubon, PA)
- …patients can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs , is responsible for preparing, filing and ... up to 10% of the time. **Essential Functions** **:** + Guides the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …food is safe or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager , Regulatory Affairs , you will play a crucial role in interpreting ... you will actively contribute to continuously developing and aligning our regulatory tools, including information systems, with our strategic objectives. You will… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Dentsply Sirona (York, PA)
- …business relationships. + Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, ... Education: + Bachelor's degree in a relevant field, such as life sciences, regulatory affairs , or a related discipline. + Regulatory Certification (such as… more
- University of Pennsylvania (Philadelphia, PA)
- …to participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager , the Regulatory ... that offer cutting-edge oncology treatments. Contingent upon funding. The ACC OCCR Regulatory Affairs Office seeks a full-time Regulatory Affairs … more
- Edwards Lifesciences (Allentown, PA)
- …ground up. **How you'll make an impact:** + As a key member of the Medical Affairs Clinical Science team, the Senior Manager (formal internal title is Senior ... Manager , Medical Affairs ) is responsible for providing scientific expertise throughout the development and implementation of clinical studies and clinical… more
- Veterans Affairs, Veterans Health Administration (Wilkes Barre, PA)
- …reports; Assures performance measures and standards issued by various accrediting, regulatory , and higher agency authorities; Performs the full range of supervisory ... reports; Assures performance measures and standards issued by various accrediting, regulatory , and higher agency authorities; Performs the full range of supervisory… more
- Veterans Affairs, Veterans Health Administration (Pittsburgh, PA)
- …the result using established quality management procedures. Knowledgeable of and complies with regulatory standards from the VA, FDA, TJC, CAP, CLIA and AABB and ... influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Complete all application requirements detailed in… more
- Veterans Affairs, Veterans Health Administration (Butler, PA)
- …or deficiencies. -Complies with applicable standards, policies, procedures, and regulatory requirements. -Provides guidance and mentorship to expand professional ... influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Complete all application requirements detailed in… more
- Veterans Affairs, Veterans Health Administration (Lebanon, PA)
- …influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Complete all application requirements detailed in ... Certified Laboratory Equipment Specialist (CLES), or Certified Healthcare Technology Manager (CHTM). Continuous maintenance of certification is not required… more
- J&J Family of Companies (Horsham, PA)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... Description:** We are searching for the best talent for Manager , Regulatory Advertising & Promotion to join...functional areas, such as Health Care Compliance (HCC), Medical/Scientific Affairs , Regulatory Affairs , Sales, Marketing,… more
- J&J Family of Companies (Spring House, PA)
- …closely with the Global Regulatory Leader (GRL) and partners across Global Regulatory Affairs as well as Project Management, Medical Writing, Clinical and ... submission. **We are searching for the best talent for Manager , Regulatory Program Manager -...degree is required, preferably in Life Sciences, Business Management, Regulatory Affairs or a related discipline. Advanced… more
