- Cardinal Health (Boston, MA)
- …plans for product development programs and regulatory submissions. **_Job Summary_** The Manager , Regulatory Affairs directs regulatory affairs ... **_What Regulatory Affairs contributes to Cardinal Health_**... authorities and provides insights to senior leadership regarding regulatory developments. The Manager leads a team… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Learn more about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** The Regulatory Affairs (RA) Program Manager Digital Strategy ... current and future products. This person will oversee collaboration between internal Olympus Regulatory Affairs Teams and external vendors as needed and will… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and technical files for registration of Olympus products in the EU. Interface with International Regulatory Affairs Team to support preparation of dossiers ... Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** Assist the Manager , Regulatory Affairs in obtaining...for registration for other international markets such as Japan, the Far East, Australia… more
- Takeda Pharmaceuticals (Boston, MA)
- …for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Manager , Global Regulatory Affairs , Marketed Products **POSITION ... : Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs , Marketed...Regulatory submissions to US FDA, EU, and other international health authorities: Manage the authoring, review cycles, finalization,… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Operations and Advocacy Projects Manager , Global Public Affairs **Location:** Cambridge, MA **About the job** We are an innovative global ... MA area_** **Main Responsibilities:** + This position is a manager role and covers a wide range of activities...projects. This position will support the VP/Head, Global Public Affairs , Specialty Care and the Global Public Affairs… more
- Olympus Corporation of the Americas (Westborough, MA)
- …(https://www.olympusamerica.com/careers) . **Job Description** The Global Lead Medical Affairs - Gastroenterology (GLMAG) is a board-certified, fellowship trained ... proficient in endoscopy with deep clinical practice knowledge, medical affairs industry experience, and/or health leadership competencies and management… more
- Takeda Pharmaceuticals (Boston, MA)
- …drug and device. + Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device Sub team to ensure that ... patients with immunologic, hematologic, and other complex diseases. The Global Regulatory Device Labeling Strategy Lead (Senior Manager ) Plasma-Derived Therapies… more
- Grifols Shared Services North America, Inc (Medford, MA)
- …8 or more years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or ... Hiring Ordinance.** Learn more about Grifols (https://www.grifols.com/en/what-we-do) **Req ID:** 527460 **Type:** Regular Full-Time **Job Category:** Regulatory Affairs… more
- Fresenius Medical Center (Waltham, MA)
- …+ Experience in project management respectively change control process + Experience in regulatory affairs or in a quality environment, ideally in a ... The internal Job Title is called **Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products).** **Main Responsibilities:** + Support as … more
- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required ... AND RESPONSIBILITIES:** + A seasoned, experienced professional with a full understanding of Regulatory Affairs ; resolves a wide range of issues in creative ways.… more
- Astellas Pharma (Westborough, MA)
- …involves close collaboration with cross-functional partners, including Manufacturing, Quality Control, Regulatory Affairs , and Supply Chain, to ensure the ... ** Manager , Quality Assurance** Do you want to be...systems. + Cross-functional Collaboration: Partner with Manufacturing, QC, Validation, Regulatory Affairs , and Supply Chain to align… more
- ICON Clinical Research (Boston, MA)
- …and preventive system to ensure continued compliance to domestic and international regulatory regulations and documentation/records requirements + Provide ... Notified Bodies) to ensure continued compliance to domestic and international regulatory regulations + Support generation of...device labeling + Work closely with Design Controls and Regulatory Affairs teams to ensure alignment of… more
- Edwards Lifesciences (Boston, MA)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex ... international regulatory environments. Working in partnership with...scientific content repository + Other incidental duties: Represent Medical Affairs in various internal and external programs **What you'll… more
- State of Massachusetts (Boston, MA)
- …of Banks is currently accepting applications for the position of IT/Cybersecurity/FinTech Manager . This role will be responsible for overseeing a team of examiners ... learn more about the Division of Banks, click here. *As an IT/Cybersecurity/FinTech Manager , you can expect to: * * Manage the supervisory activities associated with… more
- Fujifilm (Boston, MA)
- …+ Proven track record working with Marketing, Business Development, Engineering/QA, and Regulatory Affairs . + Competitive knowledge of Medical IT and Imaging ... for the Fujifilm Healthcare Americas Corporation IT portfolio. The Global Product Manager (GPM) is responsible for developing product plans, acting as a Product… more
- Cole-Parmer (Franklin, MA)
- …product line development in collaboration with Research & Development, Operations, Regulatory Affairs and Commercial teams. Implement appropriate programs to ... Job Title: Senior Product Manager , Job Title: Senior Product Manager ,...& molecular control markets. + Understanding of FDA and international regulated markets and how such regulations impact product… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Olympus (https://www.olympusamerica.com/careers) . **Job Description** The Principal Clinical Project Manager (CPM) is responsible for assisting with the execution ... strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures. + Tracks development of and… more
- Cardinal Health (Boston, MA)
- …partners across enterprise, including R&D, Regulatory , Clinical Affairs , Sourcing, Manufacturing, Strategy Functions, Downstream Marketing, International ... pediatric, and neonatal enteral feeding products. The Global Portfolio Manager is an upstream marketing leader for the global...NICU. Support developing business needs by: + Global product manager for NTrainer platform + Serve as product … more
- Takeda Pharmaceuticals (Lexington, MA)
- …program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug development ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC, Marketing). + Minimum of 5… more
- Olympus Corporation of the Americas (Westborough, MA)
- …a science-related discipline; Masters preferred. + Minimum of 15 year of directly related Regulatory Affairs experience; preferably a minimum of 10 years in a ... for travel up to 30% (deal-needs dependent); domestic and international . + Knowledge of and experience managing a Quality...Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs … more