- Catalent Pharma Solutions (Somerset, NJ)
- …Solutions in Somerset, NJ is hiring a Senior Regulatory and Compliance Specialist for the Regulatory Affairs Group. The Senior Regulatory and ... inspections. Ensure responses are completed as committed + Inform QA management where resolution of audit findings is inadequate... Quality Assurance , Pharmaceutical Manufacturing, or Compliance + Knowledge of US FDA regulatory … more
- Abbott (Pleasanton, CA)
- …and liberate more than 500,000 people with diabetes from routine fingersticks. The ** Quality Compliance Specialist ** is responsible for maintaining and ... (BSI and TUV). + Attend strategic monthly meetings and regulatory affairs ( RA ) monthly meetings....related field or equivalent experience. + 3 years in Quality Assurance , Quality Compliance… more
- Danaher Corporation (Richmond, IL)
- …cancer diagnostics and improve lives. You will be a part of the Quality Assurance and Regulatory Compliance team and report to the Director, Quality ... tools that address the world's biggest health challenges. The Specialist , Regulatory Compliance for Leica...ensure ongoing compliance while continuing to develop regulatory affairs skills. This position is part… more
- Integra LifeSciences (Princeton, NJ)
- …pathways to advance patient outcomes and set new standards of care. The Sr. Regulatory Affairs Specialist is a seasoned senior professional role responsible ... in the US, EU, Canada and globally. The Sr. Regulatory Affairs Specialist is responsible...adherence to approved product claims and regulatory compliance . + Serve as the RA lead… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs ( QA / RA ) ... it is likely not legitimate._ **Job Description** The Senior Specialist , Regulatory Affairs Operations -...required. Master's degree preferred. + Experience in medical device Regulatory Affairs , Quality Assurance… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Sr. Specialist of Regulatory Affairs you will be responsible for supporting MMS Dispensing products consisting of Medical ... regulatory impact assessments for change controls and other RA / QA items from a review and approve...certification preferred + Minimum of 5 years of strong Regulatory Affairs / Compliance experience in medical… more
- Cordis (Irvine, CA)
- …open to remote. MedAlliance (Cordis) are seeking a highly skilled and motivated Principal Regulatory Affairs Specialist to join our dynamic team. This role ... strong clinical experience and a proven track record in regulatory affairs within the medical device industry....FDA regulations and guidance. + Collaborate cross-functionally with R&D, Quality Assurance , and Clinical teams to support… more
- Abbott (Sylmar, CA)
- …experience in regulatory preferred but may consider quality assurance , research and development/support, scientific affairs , operations, or related area. ... CA currently has an on-site opportunity for a **Senior Regulatory Affairs Specialist ** with our...personnel. + Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations. + Interfaces… more
- Abbott (Alameda, CA)
- …place to work for diversity, working mothers, female executives, and scientists This **Senior Regulatory Affairs Specialist ** will work on-site out of our ... technology. **The Opportunity** As an individual contributor, the Senior Regulatory Affairs Specialist will support... Regulatory area is preferred but may consider quality assurance , software or systems research and… more
- Integra LifeSciences (Boston, MA)
- …with the Company's Notified Bodies and regulatory inquiries regarding regulatory issues/questions. + Maintains Regulatory Affairs product files ... advertising material for adherence to approved product claims and regulatory compliance . + Works in partnership with...for this position. + Bachelor's degree in science, Engineering, Regulatory Affairs , or other technically related field.… more
- West Pharmaceutical Services (Exton, PA)
- …and Post-Approval) and ensure timely execution of project objectives in line with regulatory affairs ( RA ) team's priorities. + Manage the preparation, ... Sr. Specialist , RA Project Management Requisition ID:...project manager(s) and SMEs (Subject Matter Experts) in R&D, quality assurance , clinical affairs , labeling,… more
- Fujifilm (Thousand Oaks, CA)
- …departments (eg, IT, Engineering, Facilities, Manufacturing, Regulatory Affairs , Quality Control and Quality Assurance ) to ensure achievement of ... ensure compliance of cGMP systems with all internal Quality requirements. **External US** ** QA Computerized Systems Validation (CSV) Specialist ** The … more
- Catalent Pharma Solutions (Philadelphia, PA)
- …Solutions in Philadelphia, PA is hiring a Senior Quality Assurance Supplier Specialist . This position reports to the QA Manager. The Senior QA ... **Senior Quality Assurance Supplier Specialist **...four years of experience + Strongly preferred degree in Regulatory Affairs , Biotechnology, Manufacturing, Operations, Supply Chain,… more
- Kedplasma (Port Orange, FL)
- …and procedures are followed by center personnel under the direction of the Quality Assurance Manager. Escalates any non- compliance that affects donor ... their supervisors. + Provides accurate reports of the facility's compliance to Quality Assurance Manager...Assurance Manager (QAM), Regional Manager and/or VP of QA / RA . + Assists in analyzing, tracking, and… more
- Kedrion Biopharma (Urbana, IL)
- …of the facility's compliance to QAM, Regional Manager and/or VP of QA / RA . 10. Investigate, track/trend and follow up on corrective actions and preventative ... industry and corporate policies. 2. Ensure that production personnel follows compliance of all Center activities with cGMP, Kedplasma DCOP's (Donor Center… more
- CSL Plasma (Las Vegas, NV)
- …Staff Associates for completion of training and recommendation for certification by Regulatory Affairs . Functionally directs the Center Medical Staff. Provides ... Documents each meeting. Meets with the Center Manager and Compliance Specialist (or designees) during weekly visits...to the center. Serves as a member of the Quality Assurance Team. Acts as a liaison… more
- CSL Plasma (Little Rock, AR)
- …Staff Associates for completion of training and recommendation for certification by Regulatory Affairs . Functionally directs the Center Medical Staff. Provides ... Documents each meeting. Meets with the Center Manager and Compliance Specialist (or designees) during weekly visits...to the center. Serves as a member of the Quality Assurance Team. Acts as a liaison… more
- Danaher Corporation (Fargo, ND)
- …to maintain labeling integrity. + Collaborate with internal stakeholders: Work closely with Regulatory Affairs , Quality Assurance , and Manufacturing ... improve human health. This position is part of the Quality Assurance located in Fargo, ND and...and procedures and collaborating with cross-functional teams, including Clients, Regulatory Affairs , and Marketing, to develop labeling… more
- Army National Guard Units (Marietta, GA)
- …compliance with regulatory and legal requirements. Responsible for the quality assurance , maintenance, and security of the Electronic Official Personnel ... TITLE 5 EXCEPTED SERVICE POSITION. This position is for a HR Specialist (Employee Benefits/Compensation), Position Description Number T5018P01 in support of the… more
- University of Southern California (Los Angeles, CA)
- …other study and clinical research documentation to support principal investigators and quality assurance systems for the Clinical Investigations Support Office. ... Provides regulatory affairs support, coordinating or performing a...functions and research project goals. Helps prepare and conduct high- quality compliance reviews, including close-out and reporting.… more