Regulatory specialist Jobs in Cambridge, MA
Last updated: 1 day ago
The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international expansion.
This is a hybrid role (in office 3 days per week) based...Show moreLast updated: 6 days ago
Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States.Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
We are a worldwide leader in specia...Show moreLast updated: 3 days ago
Pioneering trusted medical solutions to improve the lives we touch : Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, wi...Show moreLast updated: 6 days ago
Medical Device company as part of their regulatory affairs team, leading all SaMD, Digital Health, and AI / ML regulatory activities.
Provide leadership to assigned digital health / software project tea...Show moreLast updated: 1 day ago
Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
Participate in development and modification of th...Show moreLast updated: 6 days ago
A company is looking for a Regulatory Documentation Specialist to manage documentation activities for regulatory submissions in cell therapy.
Key ResponsibilitiesManage document preparation of CMC r...Show moreLast updated: 5 days ago
Iterative Health is a healthcare technology and services company on a mission to advance gastrointestinal care through relentless innovation.
With deep expertise in artificial intelligence and clini...Show moreLast updated: 9 days ago
PathAI is on a mission to improve patient outcomes with AI-powered pathology.We are transforming traditional pathology methods into powerful, new technologies.
These innovations in pathology can hel...Show moreLast updated: 6 days ago
Represent Regulatory Affairs ("RA") on project teams and provide regulatory guidance.Review technical documents for cGMP and regulatory compliance.
Train and coach others in regulatory requirements....Show moreLast updated: 30+ days ago
Sirtex Medical is a global leader in healthcare, with offices in the U.Australia, Germany, and Singapore, dedicated to improving patient outcomes.
Our mission is to be at the forefront of minimally ...Show moreLast updated: 1 day ago
Director, Global Regulatory Affairs.This team member will work cross-functionally to provide critical regulatory guidance throughout the product development lifecycle, manage execution of regulator...Show moreLast updated: 30+ days ago
Do you have expertise in regulatory affairs and passion for seeing the safe and effective use of pharmaceutical medicines for patients? Would you like to apply your expertise to help turn our pipel...Show moreLast updated: 13 days ago
Join us today and make a difference in people's lives!.LivaNova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improving the lives ...Show moreLast updated: 1 day ago
Determine and document change assessments for US Class II devices to ensure compliance with the US regulation.Plan and prepare submissions for US Class II devices, including creating, translating, ...Show moreLast updated: 17 days ago
- Promoted
Senior Regulatory Affairs Specialist
Katalyst HealthCares and Life SciencesBoston, MA, USFull-time
- Promoted
Regulatory Affairs Specialist III
WerfenBedford, MA, United StatesFull-time
- Promoted
Principal Regulatory Affairs Specialist, Digital Technology
Convatec Group PLCLexington, MA, USFull-time
- Promoted
Staff Regulatory Affairs Specialist (Digital Health)
Catalyst Life SciencesWoburn, MA, United StatesFull-time
Clinical Regulatory Affairs Specialist
whoopBoston, MA WHOOP is an advanced health and fitness wearable, on a mission to unlock human performance.WHOOP empowers its members to improve their health and perform at a higher level through a deeper understa...Show moreLast updated: 30+ days ago
- Promoted
Regulatory Specialist
Oxford Global ResourcesBoston, MA, USFull-time
- Promoted
Regulatory Documentation Specialist
VirtualVocationsDorchester, Massachusetts, United StatesFull-time
- Promoted
Senior Clinical Regulatory Specialist
Iterative HealthCambridge, MA, US$85,000.00–$100,000.00 yearly
Full-time
- Promoted
Principal Regulatory Affairs Specialist
PathAIBoston, MA, USFull-time
- Promoted
Senior Regulatory Specialist
Fresenius Kabi USA, LLCBoston, MA, United States$103,241.25–$133,442.00 yearly
- Promoted
Senior Regulatory Affairs Specialist
SirtexWoburn, MA, US$110,000.00–$136,000.00 yearly
Full-time
- Promoted
Regulatory Affairs Specialist
Mariana OncologyWatertown, MA, USFull-time
- Promoted
Senior Regulatory Affairs Specialist
AstraZeneca GmbHBoston, MA, USFull-time
- Promoted
Principal Regulatory Affairs Specialist
LivaNovaBoston, MA, US$125,000.00–$140,000.00 yearly
Full-time
Regulatory Affairs Specialist
InfraredX, Inc.Bedford, Massachusetts, United States, 01730 Determine and document change assessments for US Class II devices to ensure compliance with the US regulation.Plan and prepare submissions for US Class II devices, including creating, translating, ...Show moreLast updated: 19 days ago
- Promoted
Regulatory Affairs Specialist
Infraredx, a Nipro CompanyBedford, MA, United StatesFull-time
Regulatory Specialist
Commonwealth of MassachusettsBoston, Massachusetts The Executive Office of Energy and Environmental Affairs (EEA) seeks to protect, preserve, and enhance Massachusetts’ environmental resources and create a clean energy future for all residents.Thro...Show moreLast updated: 30+ days ago
Regulatory Affairs Specialist
Katalyst HealthCares & Life SciencesBoston, MA Uses relevant software to meet client EHS&T needs.Uses regulatory knowledge to provide subject matter expertise to clients and management for efficient EHS&T services when applicable.Monitors appli...Show moreLast updated: 30+ days ago
Regulatory Affairs Specialist
InfraredxBedford, MA, US Determine and document change assessments for US Class II devices to ensure compliance with the US regulation.Plan and prepare submissions for US Class II devices, including creating, translating, ...Show moreLast updated: 20 days ago
Senior Regulatory Affairs Specialist
Katalyst HealthCares and Life SciencesBoston, MA, US6 days ago
Job type
- Full-time
Job descriptionA minimum of a bachelor's degree in a scientific, technical, or related discipline. A minimum of 8 years Regulatory Affairs experience in the medical industry. Prior experience of supporting both the capital equipment as well as single-use disposables. Prior experience with 510(k) submissions, EU MDR and international regulatory registrations. Working knowledge of FDA, EU and international regulations for medical devices. Ability to read and interpret global regulations and standards. General understanding of product development process, design control and quality system regulations. General understanding of regulations applicable to the conduct of clinical trials. Prior experience supporting contract manufactured and / or OEM products. Ability to simultaneously manage several projects. Proficiency with Microsoft Office. Effective research and analytical skills. Effective written and oral communication, technical writing and editing skills. Ability to work independently with minimal supervision.
Responsibilities :
- The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international expansion.
- This is a hybrid role (in office 3 days per week) based in Marlborough, MA.
- Provides technical guidance and regulatory training / mentoring to other Regulatory Affairs employees and cross-functional teams.
- Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy / regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
- Assists with developing and implementing regulatory strategies for new and modified medical devices, as well as for OEM and Contract Manufacturer partnerships.
- Is a liaison for new business partners to provide regulatory guidance for US, EU, China, and international product registration.
- Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
- Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.
- Reviews device labelling and advertising materials for compliance with global regulations; analyses and recommends appropriate changes.
- Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
- Support and maintain Quality initiatives in accordance with BSC Quality Policy.
- Continuously assess ways to improve Quality.
- Develops and implements departmental and divisional policies and procedures.
- Supports highly technical or major business segment product lines, special projects or strategic initiatives.
Requirements :