...in which human potential is no longer hindered by the burden of disease. Description: Reporting to the Sr. Director of Regulatory Affairs and Policy, this role will support and lead activities within the Regulatory group to advance development of the assets in Wave... 
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Wave Life Sciences

Lexington, MA
1 day ago
 ...Convatec, please visit Job Summary: In this role as a Senior Regulatory Affairs Specialist at Convatec, you will be responsible for leading regulatory strategy and driving registrations across international markets for Convatec's Advanced Wound Care division. This... 
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ConvaTec

Lexington, MA
1 day ago
 ...Director in assuring Novo Nordisk compliance with internal SOPs and global regulations, including...  ...submission of any required documents to regulatory agencies.   Relationships Report to a Director of Regulatory Affairs. Develop and maintain positive rapport and... 
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Novo Nordisk

Lexington, MA
1 day ago
 ...future system development and deployment. In this role you will be a key member of our Financial Services Quality Assurance and Internal Controls (QA/IC) team, charged with reinventing our QA/IC program in alignment with finance transformation initiatives. We aim to... 
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MIT Lincoln Laboratory

Lexington, MA
3 days ago
 ...empowered to do what they do best, your best choice -- your #1 choice -- is C1. Overview: Summary The Project Coordinator Intern aids with management and support on Sales and Marketing projects. This position will work closely with our internal teams and any... 
Internship
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ConvergeOne

Lexington, MA
4 days ago
 ...Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational...  ...risks and associated mitigation plans to management and other internal stakeholders Perform or supervise regulatory review of all... 
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Novo Nordisk

Lexington, MA
more than 2 months ago
 ...through media varying at multiple time scales. Only sparse data sets are available with real-world measured data.   The Summer Intern will develop adaptive machine learning frameworks to enhance accuracy of optical beam pointing and tracking when propagating through... 
Internship
Summer internship

MIT Lincoln Laboratory

Lexington, MA
9 days ago
 ...technologies that enable air and missile defense systems to identify, track, and intercept potential threats. Business Analyst Summer Intern   The Interceptor and Sensor Technology Group currently has a summer student position for a Business Analyst. The Business... 
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MIT Lincoln Laboratory

Lexington, MA
24 days ago
 ...want a career in R&D with the opportunity to have real impact on important problems, join us!   Job Description As a summer intern in the Cyber Operations & Analysis Technology Group, you will be a full member of a research team led by a seasoned principal investigator... 
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Summer internship

MIT Lincoln Laboratory

Lexington, MA
1 day ago
  Group 81 - The Advanced Materials and Microsystems Group combines chemistry, biology, materials science, electronics, optics, photonics, microfluidics, nanofabrication, and advanced textiles to develop new technologies for a range of applications. We are developing ...
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MIT Lincoln Laboratory

Lexington, MA
9 days ago
 ...and telemetry; test set design and fabrication; data analysis; modeling; and simulation. Job Responsibilities:   The Summer Intern will contribute to efforts as part of a Lasercom prototype build program, and will take ownership of a technical project to be completed... 
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Summer internship

MIT Lincoln Laboratory

Lexington, MA
9 days ago
 ...clinical-stage programs. This includes overseeing production at internal Manufacturing Laboratory and with contracted service...  ...Working closely with Technical Operations, Quality Control, Regulatory Affairs, Supply Chain, and other teams, you'll ensure phase-appropriate... 
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Life Sciences Recruitment

Lexington, MA
3 days ago
 ...as is knowledge of Matlab or Python programming and familiarity with TensorFlow, PyTorch and/or OpenAI Gym libraries. Each selected intern will be mentored by a staff member and placed in a team to conduct research and development in one of the above and other related... 
Internship
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Summer internship

MIT Lincoln Laboratory

Lexington, MA
more than 2 months ago
The Active Optical Systems Group develops and fields unique, world-class optical sensor systems across multiple mission areas of national importance.  Our Group has a history of successful innovations; we have fielded a high-area coverage rate foliage-penetrating 3D imaging...
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MIT Lincoln Laboratory

Lexington, MA
more than 2 months ago
 ...modeling, field and flight tests, and data analysis and exploitation.     The Interceptor and Sensors Technology Group seeks summer interns to work with our dynamic and innovative teams on creative and exciting space, airborne, hypersonic, rocket, control, and optical... 
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MIT Lincoln Laboratory

Lexington, MA
more than 2 months ago
 ...the following requirements: Bachelor's degree in Clinical, Regulatory Affairs, Pharmacy, or related field or foreign academic equivalent plus...  ...and Inspections in PV and QA domains; collaborate with internal stakeholders to obtain key information and soliciting feedback... 
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Takeda Pharmaceutical Company Limited

Lexington, MA
3 days ago
 ...Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and external stakeholders including KOLs and Principal Investigators.   Essential Functions Support... 
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Novo Nordisk

Lexington, MA
9 days ago
 ...drug substance, drug product, and labeled drug product. The Director collaborates with Technical Operations, Quality Control, Regulatory Affairs, Supply Chain, and other stakeholders, to support and implement phase-appropriate solutions that protect patient safety,... 
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Kiniksa Pharmaceutical

Lexington, MA
4 days ago
 ...Job Description - Regulatory Affairs Coordinator I (3285805) Regulatory Affairs Coordinator I - ( 3285805 ) The Alzheimers Clinical...  ...processes. Assists with formal audits/QC of data and maintains internal QI program. Attends project meetings and collects and... 
Full time
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Shift work

Massachusetts General Physicians Organization

Boston, MA
10 hours ago
 ...logical decisions. Participates in inspections by regulatory bodies, such as FDA and International Notified Bodies acting as an SME for Software and Hardware...  ...Solutions, Information Technology, Regulatory Affairs, Clinical Affairs, Marketing, Production, Other Corporate... 
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Home office
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Convatec Group PLC

Lexington, MA
3 days ago
 ...3rd party Vendors where necessary to support milestone achievement. + Build and develop relationships with key internal teams, including Medical Affairs and Medical Writing. + Supports audit and inspection activities as needed. + Supports the adoption of best practices... 
Local area
Flexible hours
1 day per week

ConvaTec

Lexington, MA
2 days ago
Job TitlePrincipal Regulatory Affairs SpecialistJob DescriptionPrincipal Regulatory Affairs Specialist- Software & Artificial Intelligence...  ...study protocols.Where applicable, represent Philips in an international committee chartered to develop AI regulatory framework.You'... 
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Philips

Cambridge, MA
1 day ago
 ...registration of products while maintaining compliance with all regulatory requirements and commitments. Evaluates proposed regulations...  ...of development. Applies and advanced knowledge of U.S. and international requirements /guidelines applicable to same. Oversees global... 
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Lantheus

Bedford, MA
4 days ago
 ...Description We're looking for an Associate Director of Regulatory Affairs , working in Pharmaceuticals and Medical Products...  ...in early and late stage clinical development to advise on International filing requirements. Leads the planning, preparation (including... 
Flexible hours

PSG Global Solutions Careers

Cambridge, MA
1 day ago
 ...As leaders of the Data Science External Affairs team at Novo Nordisk, we are a dynamic and...  ...in data science and the evolving regulatory and policy landscape. As Director, Data...  ...science methodologies designed to inform both internal and external decision-making processes.... 
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Novo Nordisk

Lexington, MA
9 days ago
 ...action readiness activities by coordinating internal documentation and data reviews, tracking...  ..., and coordinating communication to regulatory authorities Applies risk assessment principles...  .... Works closely with Regulatory Affairs, Service and Quality Assurance... 

T2 Biosystems

Lexington, MA
1 day ago
 ...Practice (GCP), Pharmacovigilance (PV), internal policies, procedures and best industry practices...  ...Matter Expert (SME) to assure that all regulatory and quality compliance related to GCP’s,...  ..., pharmacovigilance and medical affairs • Provide GCP compliance oversight of... 
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Beacon Hill Life Sciences - Boston

Lexington, MA
20 days ago
 ...participation on design and risk management teams, initiation of regulatory plans for both new products and significant product...  ...Orders (as appropriate). Educate and train IL personnel on international country registration and labeling requirements to ensure that... 
Worldwide

Werfen

Bedford, MA
1 day ago
 ...Nova Biomedical is hiring a Regulatory Affairs Specialist (Level II or Senior Level) in our Waltham, MA facility (Hybrid) to focus on assuring...  ...company compliance to US 510k, Health Canada Licensing, International Device Submissions, Licensing and Registration requirements... 

Nova Biomedical

Waltham, MA
1 day ago
 ...Title: Director, Global Regulatory Affairs, Oncology Company: Ipsen Bioscience, Inc. Job Description: Director, Global Regulatory...  ...of the related Global Regulatory plans and activities with internal or external resources as appropriate and by using Ipsen... 
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Ipsen Pharma

Cambridge, MA
1 day ago