- 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
- 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
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager , Global Regulatory Labeling Strategy where you will be responsible ... EU SmPC. You will also be responsible for providing support to the development and implementation of labeling content...and requirements. + Basic knowledge of scientific principles and regulatory / quality systems relevant to drug development. +… 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
- Danaher Corporation (Marlborough, MA)
- …which makes everything possible. The Qualification Services Regulatory Program Manager for Cytiva is ... Business and Customers in a global environment by providing regulatory expertise support in ongoing projects, new...change control, and in response to customers' requests for quality , regulatory and technical-related information as it… 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
- Takeda Pharmaceuticals (Boston, MA)
- …for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Manager , CMC Regulatory Compliance (GRA, CMC) **POSITION DESCRIPTION:** Takeda ... Development Center Americas, Inc. is seeking a Manager , CMC Regulatory Compliance (GRA, CMC) with...execute on continuous improvement solutions and drive successful CMC regulatory compliance; engage in Quality Management System… 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
- Chiesi (Boston, MA)
- …than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the ... with rare and ultra-rare diseases) and **CAR** E (products and services that support special care and consumer-facing self-care). We are proud to be the largest… more
- Olympus Corporation of the Americas (Westborough, MA)
- …coordinate, develop, submit and maintain registration submissions and to provide international regulatory support throughout the product's life cycle. + Liaise ... with product RA and other stakeholders (eg R&D) to support integration of regulatory requirements into product design controls in new product developments. + … 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
- Sodexo (Boston, MA)
- …**Tufts Medical Center.** Under the direction of the Executive Director, the Compliance Manager is responsible for all Medical Center regulatory compliance in ... business!** Sodexo Facilities Solutions is seeking a **Director 2, Hospital Regulatory Compliance** in **Boston, MA** to lead our Facilities Engineering program… more
- Hologic (Marlborough, MA)
- …product development product design changes, and post-market surveillance (PMS). The Senior Quality Manager will also oversee complaint investigation, root cause ... Sr. Manager , Quality Diagnostic - Marlborough, MA...Data Analysis:** + Use data analysis to monitor trends, support quality initiatives, and ensure continuous product… more
- Hologic (Marlborough, MA)
- …topics to ensure team members are knowledgeable and compliant. + Mentor and support quality team members, fostering professional growth and development. + Plans ... Manager , Quality Assurance - Marlborough, MA...Quality Management System with applicable US and international regulatory requirements and applicable standards, including but not limited… more
- Cardinal Health (Boston, MA)
- …procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements ... and procedures and ensures that all products and services are properly reviewed for quality and documented. **_Job Summary_** The Manager , Quality Assurance… more
- Rhythm Pharmaceuticals (Boston, MA)
- …and our tenacity to overcome barriers, together. Opportunity Overview The Clinical Quality Assurance Manager will oversee GCP activities across various areas ... for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families....of development, ensuring compliance, and quality execution of clinical trials. The individual will lead… more
- Fallon Health (Worcester, MA)
- …providing timely responses to all requests for information and/or data relevant to quality activities. * Manages regulatory Quality projects, including ... of Purpose:** With general direction from the Director of Quality , the Senior Program Manager ensures that...collateral program materials, and outreach to network providers to support quality improvements. * Works collectively with… more
- Brown University (Providence, RI)
- …(https://www.brown.edu/about/administration/human-resources/benefits) for further information. About the Opportunity The Quality and Compliance (QC) Manager is a ... (https://www.brown.edu/a-z/benefits-working-brown) . Recruiting Start Date: 2024-12-12 Job Posting Title: Quality and Compliance Manager Department: Office of… more
- CVS Health (Woonsocket, RI)
- …and deliver solutions to make health care more personal, convenient and affordable. The Manager , Product Quality Operations will be a key contributor on the ... Quality Standards team who will drive the execution and...SLAs for all inquiries (24-48 hours) + Communicate and support field manager 's and store teams' understanding… 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