- 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
- Merck & Co. (Boston, MA)
- …and the Quality unit, providing necessary documentation and addressing any regulatory inquiries. Skill sets: Highly collaborative problem solver with 5+ years of ... more productive and enable innovation.We are seeking a motivated and talented Product Manager to join the RaDS Product organization. The position will report to… more
- Cytiva (Westborough, MA)
- …Specialist is responsible for ensuring the integrity of environmental monitoring, quality control testing, and sterility assurance processes in a highly regulated ... and investigations, all while ensuring compliance with industry standards and regulatory requirements.This position reports to the Contamination Control & Sterility… 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
- 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
- Dana-Farber Cancer Institute (Brookline, MA)
- The Regulatory Compliance Manager at Dana-Farber is responsible for coordinating and leading regulatory compliance activities across all sites. This role is ... on regulatory needs throughout the organization. The Regulatory Compliance Manager works under the Director...Lead Technical Support for Compliance: Manage technical support for regulatory and accreditation compliance, including… 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
- Cardinal Health (Boston, MA)
- …products. **_Job Summary_** In line with Cardinal Health business objectives, the Regulatory Compliance Manager will assist with managing Global regulatory ... of internal and external regulatory policies. Leverage broad knowledge of regulatory affairs, quality management systems and business operations to develop … 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
- 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
- Fresenius Medical Center (Waltham, MA)
- …Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required to market ... wide range of issues in creative ways. + Responsible for the preparation, compilation, quality check and delivery of regulatory submissions in both paper and/or… more
- Prime Therapeutics (Boston, MA)
- …decision we make. **Job Posting Title** Senior Functional Business Consultant/ Regulatory Compliance exp required- REMOTE **Job Description** The Functional Business ... regard to business system knowledge on internal and client projects, regulatory requirements, process improvement, advanced research, root cause analysis, complex… more
- Astellas Pharma (Westborough, MA)
- ** Manager , Quality Assurance** Do you want...+ Quality Records & Investigations: Lead or support quality investigations, risk assessments, and CAPA ... research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a ** Manager , Quality Assurance** opportunity at their **Astellas Institute for… more
- Nanobiosym, Inc. (Cambridge, MA)
- …to help the company scale up its operations. Nanobiosym is looking for a Quality Manager for its High-Complexity Testing CLIA LAB. The role and requirements ... are below. The CLIA (Clinical Laboratory Improvement Amendments) Quality Manager will provide quality ...compliant generation of clinical and validation data required to support regulatory submissions for all new products… more
- ICON Clinical Research (Boston, MA)
- Senior Manager , Quality Assurance - Farmingdale NY, Cambridge MA, Portland OR (Onsite Hybrid) ICON plc is a world-leading healthcare intelligence and clinical ... future of clinical development. We have an incredible opportunity for a Senior Manager , Quality Assurance (Medical Devices) to join ICON's Central Laboratory… more
