- Dana-Farber Cancer Institute (Boston, MA)
- …donor status including progress, challenges, and adjustments. + Ensure compliance with all regulatory bodies (eg, FDA , AABB, FACT, NMDP) related to donor ... logistical, and administrative aspects of donor services, ensuring compliance with regulatory standards and supporting overall operations of the Cellular Therapy… more
- Curia (Boston, MA)
- …transfer, qualification and validation of biologics based analytical methods using the ICH, FDA and EMA guidelines and regulatory requirements. + Multiple years ... for equipment. + Provide technical support to clients for regulatory filings, change control and quality impact assessments. +...other Curia sites. + Keep site informed for new regulatory , ICH requirements in RNA, proteins and other biological… more
- Nanobiosym, Inc. (Cambridge, MA)
- …and international tax regulations while managing government contracts and healthcare-related regulatory requirements (eg, FDA , IRB approvals, and liability ... environment and is ready to tackle a wide range of legal, regulatory , and compliance challenges. The ideal candidate is a skilled negotiator, exceptional… more
- Integra LifeSciences (Braintree, MA)
- …to resolve environmental control issues. + Ensure compliance with safety, environmental, and regulatory standards (eg, FDA , ISO). + Maintain accurate records of ... management systems (BMS) and automated environmental controls. + Knowledge of regulatory requirements in the medical device or pharmaceutical industry. + Experience… more
- Nanobiosym, Inc. (Cambridge, MA)
- …+ Prior in-house legal experience in a biotech or pharmaceutical company. + Familiarity with regulatory frameworks (eg, FDA , EMA) as they relate to IP. ... matters, including licensing agreements, collaborations, M&A due diligence, and regulatory submissions. + Dispute Resolution: Support IP litigation, opposition… more
- Oracle (Boston, MA)
- …**Oracle Cloud SCM, Manufacturing, Quality, and ERP** integrations. + Knowledge of ** regulatory compliance processes** ( FDA , ISO, cGMP) and quality documentation ... management. + Familiarity with **Oracle Visual Builder Studio** , **BI Publisher** , and **Reports** for PLM analytics. + Certification in **Oracle Cloud PLM or PDH** modules. + Strong understanding of **product data governance frameworks** and enterprise data… more
- Rhythm Pharmaceuticals (Boston, MA)
- …quarterly business reviews of programs + Ensure all speaker programs adhere to regulatory guidelines (eg, FDA , PhRMA, Sunshine Act) + Manage documentation, ... expense tracking, and reporting for transparency and audit readiness + Collaborate with Legal and Compliance teams to update policies and procedures + Create marketing materials for the field teams/HQ to promote the programs + Supervise and handle financial… more
- Danaher Corporation (Boston, MA)
- …if you also possess previous experience in: + Drug Development sales cycle and regulatory approval framework ( FDA ) + cGMP manufacturing + Sales Coaching and ... Value Selling experience Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the… more
- Hologic (Boston, MA)
- …+ Familiarity with radiology clinic IT environments, medical imaging workflows, and regulatory requirements (eg, FDA , HIPAA) + Strong grasp of cloud-based ... technologies, SaaS models, and integration with healthcare information systems (PACS, RIS, EMR) + Proficiency in market analysis, competitive intelligence, and user research to inform product strategy and roadmap + Knowledge of data privacy, cybersecurity, and… more
- Wolters Kluwer (Waltham, MA)
- …engineering teams to operate at high velocity while ensuring strict compliance with global regulatory standards such as FDA , EU MDR, ISO 13485, and IEC 62304. ... managing the software development plan and partnering with engineering, quality, and regulatory team members to aligning the process with agile and lean engineering… more