- Tecomet (Woburn, MA)
- **TITLE** : Quality Assurance and Regulatory Affairs Manager **Department:** Quality Assurance / Regulatory Affairs **Classification:** ... of QARA** **Date:** 14 July 2022 **JOB SUMMARY:** The Quality and Regulatory Manager will... will provide overall company leadership and direction for Quality Assurance and Regulatory Affairs … more
- Chiesi (Boston, MA)
- Manager , Regulatory Affairs Operations, Rare Diseases Date: Jan 10, 2025 Department: GRD Regulatory Affairs Job Type: Direct Employee Team: R&D, ... Pharmacovigilance & Regulatory Affairs Contract Type: Permanent Location: Boston,...(Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and… more
- ThermoFisher Scientific (Waltham, MA)
- …services through our industry-leading brands. Position Summary Lead the global Regulatory Affairs (RA) team and provide organizational guidance and ... be responsible for talent development within the team. Reporting to the Senior Director of Regulatory Affairs , the incumbent will serve as a member of the LPE… more
- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required ... A seasoned, experienced professional with a full understanding of Regulatory Affairs ; resolves a wide range of...in creative ways. + Responsible for the preparation, compilation, quality check and delivery of regulatory submissions… more
- Sumitomo Pharma (Boston, MA)
- …a dynamic, highly motivated, and experienced individual for the position of **Senior Manager , Medical Affairs Technology and Digital Innovation** . **Job Duties ... affairs content + Implements innovations with respect to quality control mechanisms, supportive systems/databases, efficient inquiry handling workstreams, and… more
- Fresenius Medical Center (Waltham, MA)
- …studies + Experience in project management respectively change control process + Experience in regulatory affairs or in a quality environment, ideally in a ... with the collegial culture of a medium-sized company + Supporting the department in cross-site activities to monitor product quality and regulatory compliance more
- Actalent (Cambridge, MA)
- …PharmD, or PhD preferred. + Minimum of 4 years of experience in regulatory affairs in the pharmaceutical/biotech, including IND activity, global CTAs, DSURs ... Description + Actively represent Regulatory on interdisciplinary teams (eg CMC Teams, Program...generate and refine the product development strategy. + Lead quality portions of global clinical trial applications including the… more
- Cardinal Health (Boston, MA)
- …liaison with Strategic Sourcing, Process Engineering, Design Quality , R&D, Medical Affairs , Quality Compliance and Governance, Regulatory , and other ... policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Supplier Quality is responsible for… more
- Integra LifeSciences (Boston, MA)
- …Coordinates with cross functional leaders in teams such as IS, R&D, Regulatory Affairs , and Operations, to ensure specific quality metrics are met. + Reports ... document storage, and record retention as defined in the Quality Management System (QMS). The DCT Manager ...support all training and documentation requirements adhering to all regulatory requirements for all geographies in which products are… more
- Takeda Pharmaceuticals (Boston, MA)
- …and EU standards and guidelines. Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device Sub team to ensure that ... represented at the Labeling cross functional teams including clinical, safety, medical affairs , device regulatory and commercial, to ensure highly effective… more
- ICON Clinical Research (Boston, MA)
- …progression through design phases. + Coordinate with cross-functional teams, including R&D, Regulatory Affairs , Quality Assurance, and Manufacturing, to ... our mission to shape the future of clinical development. ** Quality Manager , DESIGN CONTROLS:** **On-Site in Cambridge,...medical device regulatory process in collaboration with Regulatory Affairs and providing essential support during… more
- Cardinal Health (Boston, MA)
- …Reporting technology, Controlled Substance Ordering System (CSOS) platforms support & governance + Quality & Regulatory Affairs (QRA) technology (eg, Federal ... LRCGQ IT is accountable for all technology solutions for the Legal, Regulatory Compliance, Government Relations, & Quality (LRCGQ) organization. The team… more
- Takeda Pharmaceuticals (Boston, MA)
- …, GCP Compliance **Location** : Cambridge, MA **About the role:** As a Senior Manager , GCP Compliance, you will provide quality oversight to clinical trial ... CAPA development. + Promote knowledge management through lessons learned from regulatory inspections and quality investigations. + Participate in… more
- Dana-Farber Cancer Institute (Boston, MA)
- …Experience in an academic institution is preferred + Must have expert knowledge of regulatory affairs , research ethics and the responsible conduct of research. + ... **Division of Population Sciences** is seeking a **Senior Research Project Manager ** to oversee a portfolio of research testing behavioral interventions designed… more
- Santander US (Boston, MA)
- Branch Operations Manager , Charlestown, MA Boston, United States of America USA Job Function Description: Responsible for the administration and day-to-day ... procedures and federal and state regulations. May participate in community affairs to enhance the company's visibility and discover new business opportunities.… more
- Integra LifeSciences (Boston, MA)
- …from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs . + Project Management aimed to evaluate, analyze, ... to help improve outcomes. **SUMMARY** This position reports to the Plant Manager and is responsible for manufacturing engineering at the Integra Tissue Technologies… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …biologics, cell therapies, and other drug modalities. + Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and ... you to shape your future. Join us as a Manager of Statistics at our Cambridge, MA office, where...are addressed. + Communicate internal and external resource and quality issues that may impact deliverables or timelines of… more
- Abbott (Westford, MA)
- …teams, including manufacturing, quality assurance, research and development, and regulatory affairs , to address customer feedback and enhance product ... help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with...in Westford, MA, currently has an opportunity for a ** Manager , Engineering (Sustaining).** **THIS IS AN ONSITE DAILY ROLE.**… more
- Edwards Lifesciences (Boston, MA)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- Tufts Medicine (Boston, MA)
- …all business functions and activities to ensure efficiency, growth, professionalism and high quality of care are delivered to all patients and staff. Works closely ... patient flow. Ensures distribution of schedules to physicians and staff. Ensures quality customer service. Ensures patients and visitors are greeted promptly. 8.… more