- Nanobiosym, Inc. (Cambridge, MA)
- …while managing government contracts and healthcare-related regulatory requirements (eg, FDA , IRB approvals, and liability management). + Oversee compliance with ... all applicable laws and standards (state, federal, international) for direct-to-consumer products, clinical trials, informed consents, and risk management. + Manage risk management, including insurance coverage negotiations, and lead potential litigation with… more
- FleishmanHillard (Boston, MA)
- …field; Master's a plus. + Working knowledge of healthcare compliance requirements (eg, FDA , HIPAA, OPDP). + Strong grasp of digital measurement frameworks and how to ... connect performance data to storytelling impact. + A creative, strategic, and analytical mindset with a passion for health equity, innovation, and digital transformation. **Our Story** We're more motivated by what we can give than what we receive. That holds… more
- Integra LifeSciences (Mansfield, MA)
- …cover sterilization programs across sites. + Obtains and maintains knowledge of FDA , ISO, and EN sterilization and related microbiology standards and guidelines, for ... example knowledge on ISO 11137, ISO 11135 and environmental monitoring requirements. + Supports EU MDR compliance by performing gap analysis and formulating gap resolution plans + Subject matter expert with regard to technical assessments of contract… more
- Integra LifeSciences (Mansfield, MA)
- …+ Works in accordance with all requirements for manufacturing medical devices (eg FDA QSR, ISO 9000, ISO 13485). + Completes required documentation as required by ... process, and inspection sheets, work instructions, and the document traceability. + Lifting, 5 to 25 pounds, is required on a regular basis and heavy lifting, over 50 pounds, is required on occasion. + Ability to learn and adhere to specific procedures… more
- Hologic (Marlborough, MA)
- …Expertise in clinical study design, evidence generation, and regulatory compliance (eg, FDA , ISO, GCP). + Strong knowledge of biostatistics and proficiency in tools ... like STATA, SAS, or R. + Excellent communication and collaboration skills, with the ability to work effectively in a matrixed environment. + Proven ability to think strategically, manage multiple projects, and deliver results in a dynamic setting. **So why… more
- ThermoFisher Scientific (Boston, MA)
- …in developing and designing method transfer and validation studies per ICH and FDA guidelines is highly desired. + Proficiency in analytical techniques, such as ... HPLC, CE, iCIEF, LC-MS, Titer, SoloVPE, and impurity methods. + Prior experience with reference material qualification and inventory management is a plus. + Prior experience working with contract testing organizations (CTOs) or manufacturing sites (CDMOs) is a… more
- Olympus Corporation of the Americas (Westborough, MA)
- …of, and experience in applying / developing, products in compliance with FDA and international requirements, including 820-CFR, ISO14971, IEC60601, GMP and other ... standards as they relate to the development and manufacture of medical devices. + Capable of developing all deliverables required to document the product design with appropriate specificity to enable high volume manufacturing with high quality. + Proficient in… more
- Sanofi Group (Cambridge, MA)
- …You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements ( FDA , EMA, ICH) and lifecycle labeling best practices. + Strategic thinking ... with the ability to anticipate and influence regulatory direction across the development continuum. + Scientific rigor and analytical ability to interpret complex data and develop regulatory-sound labeling content. + Proven leadership and collaboration skills… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …clinical trials and process for regulatory submissions across difference regions (ICH, FDA , EMA and others). + Advanced knowledge and/or hands-on applications in ... integration of PK, PD, efficacy, and safety data from multiple sources for dose selection and decision-making. + Subject matter expertise in several clinical pharmacology areas and establishes oneself as a go-to colleague on a few topics. + Scientific… more
- Charles River Laboratories (Shrewsbury, MA)
- …proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal ... Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. If you are interested in applying to… more