- 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
- 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 (Boston, 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
- Medtronic (Mansfield, MA)
- …well as the regional and international teams working with integration partners to support the submission process and ensure regulatory requirements are met. ... basis to meet project schedules + Interface with engineering, quality , clinical, marketing, and other functions as needed to...in internal and external audits as needed + Maintain Regulatory affairs documentation to support compliance with… more
- Eversource Energy (Westwood, MA)
- …position is responsible for working across Eversource to identify and respond to regulatory obligations in as established by law and the Regulatory Authorities ... Functions:** + Monitors and coordinates Eversource's participation in active regulatory proceedings\. + Ensures appropriate individuals within Eversource are aware… 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
- Integra LifeSciences (Braintree, MA)
- …us are challenging what's possible and making headway to help improve outcomes. The Manager of Quality Control (QC) will oversee the day-to-day operations of the ... QC Manager will work cross-functionally with other departments to support continuous improvement initiatives and ensure that all products are safe, effective,… more
- Hologic (Marlborough, MA)
- …and confidence. The Manager of Quality Engineering will lead quality strategies to ensure compliance with regulatory requirements and the delivery of ... Manager , Quality Engineering Marlborough, MA, United...those conducted by the FDA, notified bodies, and other regulatory agencies. + Quality System Compliance: Ensure… more
- Medtronic (Boston, MA)
- …more connected, compassionate world. A Day in the Life of a Post-Market Risk, Quality Engineering Manager - reporting to Director of Post-Market Risk, Surgical ... evaluation of risk of production and field issues. * Manages the Post-Market Risk Quality Engineers in support of identifying, controlling, and taking action to… more
- Kelly Services (Norwood, MA)
- ** Quality Control Manager ** _Location: Norwood, MA (Relocating to Walpole, MA in 2026)_ _Full-Time | 10-Hour Shifts | Weekends as Needed_ _Salary: $70,000 - ... 9001 and ISO 13485, we are seeking an experienced ** Quality Control Manager ** to lead and maintain...**ISO 9001 and ISO 13485** standards and all applicable legal/ regulatory requirements. + Coordinate **internal and external audits** ,… more
- Skanska (Waltham, MA)
- Skanska is searching for a dynamic Quality Manager . This is a great opportunity to start a career with a company that builds things that matter and values its ... team. We are proud to share our culture of diversity and inclusion. The Quality Manager assists and supports Project Engineer, Project Manager , and… more
- Amazon (Westborough, MA)
- …be successful in this role. This position reports directly to the Sr. Manager of Functional Safety. Key job responsibilities * Apply and educate relevant ... team is comprised of Hardware Engineering, Technical Program Management, Advanced Quality Planning, Safety & Compliance, Reliability, Strategic Sourcing and Design… more
- Rhythm Pharmaceuticals (Boston, MA)
- …adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview The Quality Control Manager is responsible for oversight of testing performed ... medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize… more
- Sumitomo Pharma (Boston, MA)
- …a matrix team to support PV activities. **Job Duties and Responsibilities** + Support the PV operations Manager with PV operations deliverables + With ... support from PV operations manager , manages vendors to ensure the responsibilities outlined in...audits. + Global safety planning and coordination member to support global initiatives. + Collaborates with Quality … more