- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... skills, self-starter a must along with ability to maintain paperwork to FDA and company required standards. + Excellent analytical and communication skills with… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …understanding of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory ... etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable. **Competencies** **Accountability for… more
- Teleflex (Wyomissing, PA)
- …projects are developed and documented in compliance with the Quality System and with FDA and ISO standards. * Comply with Teleflex's Code of Ethics, all company ... * Familiarity with design control processes, regulatory requirements (eg, ISO 13485 and FDA 21 CFR 820) and quality standards for medical devices. * Understanding of… more
- Sanofi Group (Swiftwater, PA)
- …Inspections. + Covers an international scope including major regulators; US FDA (USA), EMA (Europe), ANSM (France), National Medical Products Administration (China), ... experience preparing for and supporting Regulatory Inspections from Regulators (eg, US FDA , ANSM, PMDA, NMPA, EMA, MHRA, etc.) + Action oriented, results driven,… more
- Philips (New Kensington, PA)
- …the right fit if:** + You've acquired a minimum of 8+ years' experience in FDA Regulated Post Market Surveillance (PMS), with a focus in Corrections & Removals (21 ... leadership of Post Market Surveillance/C&R teams, detailed knowledge in FDA and Global Medical Device regulations, strong communication and collaboration… more
- Merck (North Wales, PA)
- …across all documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, and written ... leading or supporting direct interactions with major Health Authorities (eg, FDA , EMA). + Demonstrated success in managing regulatory filings across global… more
- University of Pennsylvania (Philadelphia, PA)
- …close out visits with Sponsor of CRO; adhere to all PENN, ICF, and FDA guidelines; prepare and process all IRB documentation. The clinical research coordinator B ... close out visits with Sponsor of CRO; adhere to all PENN, ICF, and FDA guidelines; prepare and process all IRB documentation. The clinical research coordinator B… more
- Envista Holdings Corporation (Quakertown, PA)
- …that the company's products comply with the US Food and Drug Administration ( FDA ), local and state agencies and global health authority and agency regulations. + ... of experience in progressive Quality Assurance role and exposure to FDA regulations/ISO 13485 requirements. + Experience with statistical software packages such… more
- Bayer (Philadelphia, PA)
- …Medical Inquires in collaboration with Medical Communications; + Adherence to SOP and FDA guidance for distribution of scientific information; + Adherence to SOP and ... Pharmacy, Medicine, Nursing or equivalent experience is preferred; + Working knowledge of FDA , OIG requirements; + A minimum of 1 year MSL experience or 2… more
- Globus Medical, Inc. (Audubon, PA)
- …specifications for new product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project + Managing all ... and market plans + Assisting in the writing of regulatory applications to the FDA and other regulatory bodies + Partnering with the operations department to setup… more