Head of Quality & Regulatory — Medical Devices
Eyebot
Eyebot is on the lookout for a Head of Quality to lead their quality and regulatory function as they expand. The ideal candidate will drive regulatory strategies, develop a robust QMS, and ensure compliance with FDA and international frameworks. This is a full-time role based in Boston’s North End. We offer a competitive salary range of 150k-220k, equity options, flexible working arrangements, and a collaborative environment committed to innovative vision care solutions. #J-18808-Ljbffr Eyebot
- ...vision care, we would love to hear from you. About The Role We are looking for a Head of Quality to build and lead Eyebot’s quality and regulatory function as we scale our medical device operations across the United States and prepare for expansion into the European...RegulatoryMedical deviceFull timeWork at officeFlexible hours
$238.3k - $327.66k
...professional, looking for the next step in your career. As Head of Endovascular Robotics (EVR) Quality & Regulatory Affairs, you will be responsible for overseeing... ...management of products through the lifecycle of medical device product development. Experience with applying...RegulatoryMedical deviceTemporary workWork at officeLocal area$285k - $350k
ABOUT THE ROLE The Head of Quality is responsible for providing strategic and operational Quality oversight for manufacturing, clinical... ...The Head of Quality will work cross-functionally with CMC, Regulatory, Clinical Operations, Clinical Supply, Technical Operations...RegulatoryFixed term contract- ...products are safe and effective for clinical use, supporting regulatory submissions through V&V activities. Your responsibilities include... ...engineering or related field and experience in the medical device industry. Join us in transforming healthcare and improving lives...RegulatoryMedical device
- ...Venus AI is seeking a Vice President, Regulatory Affairs, Quality Assurance & Quality Control. This senior role involves leading regulatory... ...compliance, and optimizing quality management systems within the medical device industry. The ideal candidate will have over 10 years...RegulatoryMedical device
- ...Software Solutions, located in Boston, MA, is hiring a Senior Design Quality Engineer to ensure compliance with design control regulations.... ...in quality engineering, and a strong understanding of regulatory standards. The position offers a competitive salary and benefits...RegulatoryMedical device
- ...A healthcare technology company is seeking a Sr. Regulatory Affairs Specialist in Somerville, Massachusetts, to support the commercialization of its digital products and AI technologies. The role involves providing regulatory input on product development, maintaining...RegulatoryMedical deviceRemote work
- ...LLC in Boston is seeking a candidate with a strong background in medical devices and combination products. Responsibilities include authoring design control documentation, ensuring compliance with regulatory standards, and supporting product development. Candidates...RegulatoryMedical device
$238k - $374k
JobRx, Inc. is seeking an Executive Director of Global Regulatory Affairs in Boston, MA. This leadership role requires over 20 years... ..., with significant expertise in regulatory submissions for medical devices and combination products. You will oversee a team to develop...RegulatoryMedical device$199.56k - $246.51k
...and we are all in, are you? Job Summary The Director and Head of GCP/GVP/GLP Quality is a leadership role responsible for both strategic and... ...represents Development Quality in interactions with global regulatory authorities and external partners on GCP, GVP, and GLP‑...RegulatoryWork at officeRelocationFlexible hours- ...Approval (PMA) submission of a Class III long-term implantable medical device within the Implantable Device Unit (IDU). This role will... ...design, verification and validation, manufacturing readiness, and regulatory submission activities. The Project Manager will partner...RegulatoryMedical device
- A leading medical device company in Boston is seeking a Quality Manager who will oversee validation and verification processes for new products. The role involves... .... Strong analytical skills and knowledge of regulatory requirements are essential. This position offers a...RegulatoryMedical device
- A leading medical device company based in Boston is seeking a Senior R&D Engineer. In this role... ..., ensuring compliance and high-quality standards. You will also mentor junior... ...industry and a strong understanding of regulatory requirements. This position offers competitive...RegulatoryMedical device
- ...Engineer to support production readiness and optimize processes for medical technology products. In this hands-on role, you will... ...engineering and 3-7+ years in manufacturing engineering, focusing on regulatory environments. The position offers unlimited paid time off and...RegulatoryMedical device
$92k - $138k
Medtronic is seeking a Senior Regulatory Affairs Specialist in Boston, Massachusetts. This role is primarily responsible for managing regulatory activities for the Basic Energy and Access and Instrument product portfolio. Duties include preparing submissions, interacting...RegulatoryMedical device- A global health innovation company is seeking an Executive Director for Global Regulatory Affairs to lead strategic initiatives for medical devices and drug-device combination products. The role requires over 20 years of industry experience with significant expertise in...RegulatoryMedical deviceWorldwide
- A medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class II medical devices. Responsibilities include managing FDA submissions, ensuring regulatory compliance throughout product development, and collaborating...RegulatoryMedical device
- We are seeking an experienced Design Quality Lead to support Digital Health Technology (DHT) and Software as a Medical Device (SaMD) initiatives within a highly regulated medical... .... This role will provide quality and regulatory oversight for AI-enabled medical technologies...RegulatoryMedical device
$181k - $286.96k
...Cambridge, MA is seeking a Director of Quality for Internal Audit and Compliance Engineering... ...program and ensuring compliance with regulatory requirements. Candidates should have at least 15 years of experience in the medical device industry, including experience with FDA...RegulatoryMedical device3 days per week- ...Job Title: Director of Regulatory Affairs Job Description: As the Director of Regulatory Affairs in the medical device industry, you will play a pivotal role in ensuring that... ...cross-functional teams, including R&D, quality, and marketing, to align product development...RegulatoryMedical device
- ...Job Title Manage line of FDA regulated products: Consumer medical devices (hot/cold packs, pregnancy test kits, drug test kits), OTC... ...obtain and distribute updated information, timely. Interpret regulatory rules or rule changes and ensure that such are communicated...RegulatoryMedical device
- ...About the job Senior Manufacturing Engineer Medical Device The Senior Manufacturing Engineer plays a key role in bridging... ...development to commercialization. The role emphasizes efficiency, quality, regulatory compliance, and cost-effectiveness while collaborating...RegulatoryMedical deviceContract workWork at office
- ...supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global... ...satisfaction rating. Our mission is to deliver high-quality service and technology solutions – rooted...RegulatoryMedical deviceRemote workWorldwide
$92k - $138k
Medtronic plc seeks a Sr Regulatory Affairs Specialist based in Boston, Massachusetts. This role involves planning and executing regulatory strategies for Class II robotic medical devices. The ideal candidate will work closely with cross-functional teams to ensure compliance...RegulatoryMedical device- Eight Sleep is looking for a Director of Medical Products to build a medical business... ...sleep and health. The role includes leading regulatory and reimbursement strategies,... ...has over 6 years of experience in medical devices, a successful track record of FDA clearance...RegulatoryMedical device
- Philips Iberica SAU is seeking a Quality Assurance Specialist for Device History Record in Cambridge, Massachusetts. This role is vital in ensuring compliance with regulatory and internal standards for medical device manufacturing. Responsibilities include reviewing records...RegulatoryMedical deviceHourly payFull time
- A global medical device company is seeking a Senior Project Coordinator in the Boston area to support system separation initiatives... ...while coordinating with director-level leadership in Quality, R&D, and Regulatory Affairs. The ideal candidate will have strong...RegulatoryMedical device
$109.1k - $135k
Philips International seeks a Senior Regulatory Affairs Specialist in Cambridge, MA to support regulatory needs for Sleep & Respiratory... ...substantial experience in Regulatory Affairs within the Medical Devices Industry. The role includes developing regulatory strategies...RegulatoryMedical device- ...leading health-technology company in Cambridge, MA, is seeking a Quality Systems Engineer to manage quality processes and ensure... ...will have over 5 years’ experience in quality operations within medical device manufacturing and will be responsible for risk assessments,...RegulatoryMedical deviceFull time
$122.25k - $176.58k
Mass Digital Health is seeking a Manager of Regulatory Affairs to join their team in Cambridge, MA. The role involves conducting independent... ...and 1-3 years of relevant experience in pharmaceutical or medical device regulatory affairs. The salary range for this role is $122,25...RegulatoryMedical device
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