- Kelly Services (Norcross, GA)
- …and enjoys driving strategy and collaboration across scientific, clinical, and quality teams. **Key Responsibilities** + Lead regulatory strategy development ... dossiers** . + Serve as the primary liaison with regulatory agencies, including the ** FDA , EMA, and...Class III device submissions** , **clinical studies** , and ** quality systems implementation** . **Technical & Leadership Skills:** +… more
- Dana-Farber Cancer Institute (Boston, MA)
- …documents for SRC and IRB review and approval. + Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, ... Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the...regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + Prepares,… more
- UTMB Health (Galveston, TX)
- …funding agencies to design and execute regulated nonclinical studies compliant with the US FDA GLP regulations or under quality systems that utilize the US ... FDA GLP regulations as a reference standard. The Regulatory Scientist I / II may also function as a Principal Investigator for extramurally funded research… more
- Medtronic (Minneapolis, MN)
- …technical experts to resolve potential regulatory issues and questions from regulatory agencies. + Prepare FDA , European, and Canadian submissions for ... regulatory issues and questions. + Interact directly with FDA and international regulatory agencies on most...EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards. + **Strong… more
- Philips (Bothell, WA)
- …new product development projects, ensuring our state-of-the-art Ultrasound Products meet FDA , and other governmental agency/notified body Regulatory Compliance ... reviewed with the RA management. + Driving improvement in regulatory aspects of the Quality Management System...if:** + You have a minimum of 8+ years' Regulatory Affairs experience within FDA regulated Medical… more
- Boehringer Ingelheim (St. Joseph, MO)
- …linking regulatory affairs information to internal and external stakeholders ( FDA ) to ensure sufficient and efficient communication through activities such as ... governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or subteam member in… more
- Access Dubuque (Dubuque, IA)
- …Metrix Company, a leading manufacturer of single-use medical devices, is seeking a quality -driven Regulatory Affairs Specialist to join our team. This person ... regulatory agencies. Other duties include: + Assures regulatory compliance to ISO 13485, FDA 21...based on corrective / preventive action (CAPA's) investigations of regulatory / quality issues. + Analyzes complaints… more
- Dana-Farber Cancer Institute (Boston, MA)
- …Reg unit, the Regulatory Operations Manager (ROM) will oversee the CTIP Regulatory Unit, manage the development and quality control of protocol documents ... (along with Regulatory coordinators) is responsible for closely managing regulatory submissions and communication process, following a quality control… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …drug products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting ... as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality , Manufacturing, Global Regulatory Strategy). + Assess and provide … more
- Pentax Medical (Montvale, NJ)
- …+ Work in partnership with manufacturing and QA/QC in designing and enhancing quality management systems to facilitate overall regulatory compliance. + Reviews ... new regulatory developments. + Maintain list of regulatory and quality standards relevant to the...related field (Masters preferred) + Three-five years' experience in Regulatory Affairs for a FDA regulated employer… more