- Catalent Pharma Solutions (St. Petersburg, FL)
- …controls areas, and by providing appropriate chemical/ regulatory knowledge and support. The QA / RA Compliance Specialist will interact directly with ... ** QA / RA Compliance Specialist...** QA / RA Compliance Specialist ** **Position...preferred. + Prior regulatory affairs , quality control or quality assurance … more
- 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
- Adecco US, Inc. (Swiftwater, PA)
- …with 2+ years Regulatory Affairs experience OR Master's degree in Regulatory Affairs / Quality Assurance or an appropriate combination of other ... Healthcare & Life Sciences is hiring a contract hybrid Regulatory Affairs Specialist for our...The Regulatory CMC Specialist in Regulatory Site Office supports regulatory compliance… more
- Integra LifeSciences (Braintree, MA)
- …us are challenging what's possible and making headway to help improve outcomes. The Regulatory Affairs Specialist is an intermediate level role responsible ... regulations in the US, EU, Canada and globally. The Regulatory Affairs Specialist is responsible...and other Quality System Documentation that requires regulatory review and approval to ensure compliance … 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
- Abbott (Santa Clara, CA)
- …the treatment of structural heart disease. **The Opportunity** We are recruiting for a ** Regulatory Affairs Specialist ** to join our team on-site in Santa ... Clara, CA.As an individual contributor, the function of a Regulatory Affairs Specialist II is... Regulatory area is preferred but may consider quality assurance , research and development/support, scientific … 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 (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
- 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 (St. Paul, MN)
- …experience in regulatory preferred but may consider quality assurance , research and development/support, scientific affairs , operations, or related area. ... disease. **The Opportunity** We are recruiting for a **Senior Regulatory Affairs Specialist ** to join...submission and approval requirements. Participate in risk-benefit analysis for regulatory compliance . + Monitor impact of changing… more
- Integra LifeSciences (Harrisburg, PA)
- …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
- 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 (Rochester, NY)
- …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
- Integra LifeSciences (Princeton, NJ)
- …are challenging what's possible and making headway to help improve outcomes. The Regulatory Affairs Specialist is responsible for implementing regulatory ... and upcoming regulations in the US and EU. The Regulatory Affairs Specialist is responsible...and other Quality System Documentation that requires regulatory review and approval to ensure compliance … 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
- 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