- 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
- Deloitte (Boston, MA)
- …and more efficiently. With Deloitte's AI & Data, our clients have the support they need to continuously develop, innovate, automate, scale, and operate in service ... a digitally enabled, equitable future of health As a Manager you will lead and deliver small engagements, or...will craft solutions for clients, guide and oversee the quality of your team's deliverables and recommendations, as well… 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
- 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
- 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
- Sanofi Group (Framingham, MA)
- **Job Title:** Manager , External Manufacturing, North America Quality **Location:** Framingham, MA **About the Job** We deliver 4.3 billion healthcare solutions ... hope to patients and their families. Your job, as Manager , External Manufacturing, North America Quality , will... to the team, as well as ensuring the quality and regulatory compliance of products in… 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
- 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
- Pfizer (Andover, MA)
- …areas walkthroughs (Area product clarences, GMP and compliance walkthroughs) - Assist Quality Operations Deviations and Product Floor Support for all planned ... to ensure compliance with configuration management policies. As a Manager , your breadth of knowledge on internal or external...to assure compliance with regulatory standards and regulatory filing. - Quality Assurance approval of… more