- Pfizer (Collegeville, PA)
- …contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports ... the side of the sponsor and with a track record of successful regulatory submission, inspection, and regulatory approval. Excellent knowledge of clinical… more
- GRAIL (Harrisburg, PA)
- …advanced degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions ... information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership...and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US… more
- Dentsply Sirona (York, PA)
- …device industry. + Experience with leading regulatory submissions and managing regulatory projects. + In-depth knowledge of FDA 510(k) and international ... + Prior technical writing experience and proven track record with FDA and EU regulatory submissions. + Excellent interpersonal skills. + Ability to work… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …claims. + Author and/or review regulatory submissions, specifically device master files, regulatory support files, and meeting requests to FDA and other ... experience strongly preferred. **Knowledge, Skills, Abilities:** + Extensive knowledge of regulatory requirements, including those from the FDA , Health Canada,… more
- Sumitomo Pharma (Harrisburg, PA)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international ... to support proposed claims and assess consistency of proposed claims with FDA -approved labeling + Provide regulatory leadership to the respective… more
- Globus Medical, Inc. (Audubon, PA)
- … Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to ... conformance to 21 CFR regulations. + Assists with other regulatory matters as requested. + Attends FDA ...other regulatory matters as requested. + Attends FDA meetings as requested. + Understands relevant surgical techniques… more
- University of Pennsylvania (Philadelphia, PA)
- … Affairs Specialist-CC will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable ... resources, and much more. Posted Job Title Clinical Research Regulatory Specialist B (Abramson Cancer Center) Job Profile Title...FDA , as well as, organize and maintain all regulatory affairs documentation/files as required. The Regulatory … more
- Oracle (Harrisburg, PA)
- …for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Excellent cross-functional communication and documentation skills. Preferred: . Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k),… more
- Oracle (Harrisburg, PA)
- …for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Excellent cross-functional communication and documentation skills. Preferred: . Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k),… more
- Pfizer (Collegeville, PA)
- …Finance, PX, , Legal, and PGS + Works with external contacts including Regulatory Authorities ( FDA , EMA, MHLW etc), professional scientific and regulatory ... **JOB SUMMARY** Global Regulatory Sciences (GRS) serves as strategic leader and...the product life cycle. The Vice President, Internal Medicine Regulatory Strategy, serves as a senior regulatory … more
