- 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
- Medtronic (Mansfield, MA)
- …development and review process + Provide business and product information to the international regulatory affairs team to enable development and strategies ... Day in the Life** We are seeking a Senior Regulatory Affairs Specialist to join our team...+ Review promotional and advertising material + Maintain current regulatory knowledge of domestic and international regulations,… 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
- Grifols Shared Services North America, Inc (Boston, 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
- Sumitomo Pharma (Boston, MA)
- …supplies on multiple clinical programs. In addition, working closely with CMC, Regulatory Affairs , Quality Assurance, Clinical Operations, and /or SMPA external ... motivated, and experienced individual for the position of **Senior Manager , Clinical Supply Chain** . The Senior Manager...local regulations. + Collaborate closely with Clinical Operations, CMC, Regulatory Affairs , QA, and PDM to ensure… 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
- 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
- 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
- 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
- Abbott (Boston, MA)
- …Directors, Senior Management, Marketing, Training & Education, Research & Development, Regulatory & Clinical Affairs , Reimbursement, Customer Service, and ... also have access to: + Career development with an international company where you can grow the career you...Tradeshows as requested by management . Immediately report to Regulatory any product failures or customer complaints . Shares… 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
- Takeda Pharmaceuticals (Cambridge, MA)
- …facilitating cross-functional engagement with stakeholders across Clinical Development, Global Regulatory Affairs , Global Manufacturing Sciences, Global Product ... & Launch Strategy, Global Communications, and Global Medical Affairs , as well as regional launch leads in the...on critical path tactics. Collaborate with the Global Program Manager (GPM) and regional launch leads to align timelines… more