- Cytiva (Marlborough, MA)
- …about the Danaher Business System which makes everything possible.The Quality and Regulatory Support Manager for Cytiva is responsible for supporting the ... Business and Customers in a global environment by providing quality documents and regulatory support in ongoing projects, new product development, change… more
- Cytiva (Shrewsbury, MA)
- … support effective design transfers and product launches.This position reports to the QA Senior Manager Site Quality Leader and is part of the Quality and ... in engineering, Health Sciences, or a related field.Minimum 5 years of experience in Quality or Regulatory in a regulated industry (ISO 9001, medical device, or… more
- Danaher Corporation (Marlborough, MA)
- …the Danaher Business System which makes everything possible. The Quality and Regulatory Support Manager for Cytiva is responsible for supporting the ... Business and Customers in a global environment by providing quality documents and regulatory support in ongoing projects, new product development, change… more
- Cole-Parmer (Franklin, MA)
- Job Title: Sr. Manager , Quality and Regulatory Assurance Reports To: VP, Quality Position Location: Franklin, MA FLSA Status (Exempt/Non-Exempt): FLSA ... Status: Exempt Position Summary: The Senior Manager , Quality and Regulatory Assurance...Channel Management, Purchasing, Receiving, Manufacturing, Shipping, Sales and Customer Support . In addition, this position works closely on the… more
- Fresenius Medical Center (Waltham, MA)
- …Manager (m/f/d) - Sterile Fluids (Medicinal Products).** **Main Responsibilities:** + Support as regulatory expert development and new registration projects ... documentation (eg, CMC relevant parts) + Organize and support global creation and maintenance of regulatory ...project management respectively change control process + Experience in regulatory affairs or in a quality environment,… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …including clinical development, marketing authorization application preparation and submission, regulatory support to commercialization and management of ... The Sr. Manager , CTA Regulatory Strategy is responsible for providing critical support in developing global regulatory strategy, planning, and execution… more
- TD Bank (Boston, MA)
- …management in delivery of initiatives related to risk assessment, internal/external exam support , etc. The Governance, Regulatory Response and Reporting team is ... for complex situations + Complies with applicable internal and external audit and regulatory requirements and may actively provide support during Audit and … more
- AbbVie (Cambridge, MA)
- …(RSTP) for assigned on market products or those products in development. The Manager assists Regulatory Staff by identifying and gathering data needed to ... for a product(s) within Neuroscience and supports the Manager (Senior Manager , Associate Director, Director (Global Regulatory Lead (GRL)), in the… more
- Olympus Corporation of the Americas (Westborough, MA)
- …more about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** The Regulatory Affairs (RA) Program Manager Digital Strategy is ... trainings to ensure DU employees maintain best practices in regulatory aspects of product development. + Support ...Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs… more
- Olympus Corporation of the Americas (Westborough, MA)
- …about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** Assist the Manager , Regulatory Affairs in obtaining approval to market ... of Olympus products in the EU. Interface with International Regulatory Affairs Team to support preparation of...Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs… more
- Takeda Pharmaceuticals (Boston, MA)
- …patients with immunologic, hematologic, and other complex diseases. The Global Regulatory Device Labeling Strategy Lead (Senior Manager ) Plasma-Derived Therapies ... and guidance. + Assists in the development of innovative regulatory strategies for labeling development to support ...quality and consistency across products and compliance with regulatory labeling guidance. + Project manages new or updated… more
- Philips (Cambridge, MA)
- The Regulatory Affairs Program Manager will play a critical role within Philips Patient Safety & Quality Organization, responsible for enhancing tracking and ... controlling systems to optimize regulatory compliance monitoring and reporting efficiency, implementing robust systems and processes to ensure accurate and timely… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed ... and regulatory obligations. **J** **ob Responsibilities** - Provides critical support in developing global regulatory strategy, planning and execution of… more
- Orchard Therapeutics (Boston, MA)
- …development strategy. . Support the planning, preparation and submission of high- quality Regulatory CMC content for submissions, such as meeting materials, ... Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company. At Orchard, the Regulatory Team provide Regulatory and Chemistry, Manufacturing and Control… more
- Grifols Shared Services North America, Inc (Medford, MA)
- …to guide the scope of experimentation and the selection of data needed to support regulatory submissions. + Interacts with regulatory authorities regarding ... devices or new indications for existing products + Provides regulatory expertise to Research and Development to support...May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of… more
- Grant Thornton (Boston, MA)
- As a Regulatory & Practice Review Seasonal Senior Manager you'll support audit teams for regulatory inspection with all with the resources, environment, ... and support to help you excel. Your day-to-day may include:...include: + Supporting audit teams that are selected for regulatory inspection + Communicating and interaction with the firm's… more
- Abbott (Westford, MA)
- …to complete them. + Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed. + Maintain ... drive proactive quality system improvements + Represent Quality Systems as required in support of...+ Represent Quality Systems as required in support of cross-functional divisional projects. + Identify Quality… more
- Medtronic (Boston, MA)
- …directly with new product development and sustaining teams to develop the global regulatory strategy and support regulatory activities throughout the product ... regulatory requirements and partners with the international regulatory affairs group to support regulatory...across the business unit, including but not limited to Regulatory Affairs, Research and Development, Clinical, Quality ,… more
- East Boston Neighborhood Health Center (Revere, MA)
- …user for the Compliance department. Medicare Audits + In partnership with the PACE Regulatory Compliance Manager , flags CMS audit compliance issues based on risk ... who lead and guide our staff, to the many support roles that keep our facilities running smoothly -...Locations: 300 Ocean Avenue - Revere Position Summary: The Regulatory Compliance Analyst will perform a wide range of… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …for RAS Therapeutics is looking for a Regulatory Coordinator (RC) to provide regulatory support for this new initiative. The RC will work under the direction ... Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the...guidance and or local policies + Assists Clinical research Manager with regulatory based training and implementation… more
