- GRAIL (Boston, MA)
- …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 (Waltham, MA)
- …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 (Waltham, MA)
- …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 (Boston, MA)
- …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
- 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, ... appropriate regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + Prepares, maintains and… more
- Oracle (Boston, MA)
- …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 (Boston, MA)
- …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 (Cambridge, MA)
- …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
- IQVIA (Boston, MA)
- …to make a significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Oncology is preferred. ... from discovery to market. You will oversee preclinical strategy, clinical strategy, regulatory strategy, and commercial strategy, and assess the risk and probability… more
- Hologic (Marlborough, MA)
- …input for audits and FDA submissions. + Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance and standards, such as ISO, ... regulated environment is required. + Thorough familiarity with FDA and other regulatory body Cybersecurity Guidelines and cybersecurity standards such as NIST,… more