Medical Device Labeling Lead: EUMDR & ISO Compliance
HCLTech
HCLTech is seeking a Medical Device Labeling specialist to lead labeling projects for NPD and current products in Milpitas, CA. You will create/update label artworks, manuals, and design control documents, while coordinating with offshore teams and cross-functional partners. Experience in regulated environments and EU MDR is advantageous. The role offers full-time employment with pay range and benefits. You will work with PLM tools and ensure compliance with EUMDR, FDA, and ISO standards. #J-18808-Ljbffr HCLTech
- ...Dragonfly through FDA clearance and international market authorization. This high-impact, high-ownership role places you as the regulatory SME, collaborating with engineering, clinical, and quality teams to move fast without compromising compliance. #J-18808-Ljbffr TiposiMedical device
- ...for a 12-month contract onsite in Santa Clara, CA. The role focuses on centralized execution of international addendum labeling within the medical device portfolio and requires collaboration across Regulatory Affairs, Quality, Supply Chain, Packaging, Manufacturing, and...Medical deviceContract work
$45 per hour
...talented and self- motivated Medical Device Labeling specialist to join it in... .../Responsibilities Manage / lead / execute labeling project(s... ...labels and user manuals as per EUMDR requirements Manage transactions... ...on EUMDR, 21CFR 820, ISO 13485, ISO 14971, ISO 15223,...Medical deviceHourly payFull timeLocal area- ...Regulatory Specialist in Santa Clara, CA to lead international labeling initiatives and ensure regulatory compliance across product portfolios. The role involves... ...or related fields, with strong knowledge of medical devices and labeling requirements, and excellent project...Medical device
- System One is seeking a Compliance Specialist III in Mountain View, California, for a 6-month contract... ...quality and regulatory compliance for medical device manufacturing, ensuring adherence to FDA regulations and ISO standards. Responsibilities include managing...Medical deviceContract workWork at office
$146.3k - $244.1k
...committing to the values that lead to great work. Every new... ...Auditor to support regulated medical device features. If you are passionate... ...to ensure ongoing regulatory compliance and encourage continuous improvement... ...audits in accordance to ISO 13485, MDSAP requirements, China...Medical deviceRelocation- ...documentation for design verification/validation, software and process validations, risk analysis, and human factors. Lead CAPA and ensure compliance with QMS and regulatory requirements. You will support production, troubleshoot issues with contract manufacturers, and...Medical deviceContract work
- ...hour week, focusing on regulatory strategy and global submissions for medical devices across the US, Canada and beyond. You will lead FDA 510(k) submissions, coordinate with teams, and ensure compliance with US, Health Canada and EU MDR regulations, while aligning with...Medical deviceContract work
- Intuitive in Sunnyvale, CA seeks an experienced Regulatory Affairs professional to provide expert leadership in global submissions and compliance strategy. The role focuses on cross-functional coordination, technical documentation, and agency interactions to support product...Medical deviceWorldwide
- ...Global Clients America seeks an experienced EHS Manager on a 5-8 month contract to lead health, safety and environmental programs at a Sunnyvale site. You will oversee ISO/OSH compliance, audits, training, and risk assessments, coordinating with onsite management and security...Contract work
$146.3k - $244.1k
A leading technology company in Cupertino is seeking a Senior Lead Auditor to support their... ...internal and supplier audits to ensure compliance with regulatory standards. Ideally,... ...employee benefits such as stock options, medical coverage, and educational reimbursements...Medical device- ...Inc. is seeking a Software Manager to lead the ultrasound imaging platform development... ...engineers, and ensure regulatory compliance while collaborating with hardware, UX,... ...a strong C++ background, experience in medical devices, and proven leadership in fast-growing...Medical device
$26 - $28 per hour
...Medical Device Manufacturing Operators, Product Builders, and Assemblers ***6 month+ assignment possible... ...a Controlled Environment Room (CER) Ensure compliance with quality and regulatory standards (QSR, MOD, CMDR, ISO) Preferred Experience: ~1+ year of medical...Medical deviceContract workFlexible hoursShift work$218.3k - $363.7k
International Regulatory Affairs Lead (Medical Devices) Cupertino, California, United States - Hardware We are looking for an International Regulatory... ...Significant expertise in global quality standards, including ISO 13485, ISO 14155, and related technical product‑specific...Medical deviceRelocation package$109k - $174.8k
...Senior Regulatory Affairs Program Lead - Instrumentation &... ...feedback for specifications, device testing, risk management, and... ...development, support of claims, content labeling, and promotional materials.... ...Regulatory Affairs experience within Medical Device (4+ years with Advanced...Medical deviceLocal areaImmediate start- ...Novo, PMA, BDD/Q-Sub) and EU MDR pathways Lead preparation and submission of regulatory... ...Own and maintain risk management files per ISO 14971 and usability/human factors... ...needed Track and interpret evolving global medical device regulations and translate them into actionable...Medical device
- ...Regulatory Specialist Our client, a leading organization in the medical device industry, is seeking a Regulatory Specialist to join their team... ...Affairs Operations team supporting international labeling and compliance initiatives. The ideal candidate will have strong...Medical deviceWeekly payTemporary workFlexible hours
- ...Manager / Associate Director of Quality Systems & Audits to lead global internal audits and coordinate external... ...position requires 8-10 years in QA within FDA-regulated or ISO-certified labs or medical devices, with 5+ years in leadership. #J-18808-Ljbffr TryApplyNowMedical device
- ...procedures and practices to ensure compliance with FDA and international... ...would have had previous medical device experience and looking for... ...design, manufacturing, and labeling changesRepresent RA functional... ...Management System Standard ISO 13485 is requiredExperience...Medical deviceWork at office
- A leading health technology firm is seeking a Regulatory Affairs Specialist to manage regulatory submissions and compliance activities for innovative medical devices. The ideal candidate will have a Bachelor’s degree and significant experience in the medical device industry...Medical device
- Apple Inc. in Cupertino, CA is seeking an International Regulatory Affairs Lead to head a team responsible for the international expansion of Apple Health’s regulated medical device features. This strategic role focuses on leading regulatory programs, developing global...Medical device
- ...seeking a Principal Regulatory Affairs Associate for their health products team. This role involves leading regulatory initiatives to obtain approvals for innovative medical devices, requiring 10+ years of medical device regulatory experience and a B.S. in Engineering. The...Medical device
$138.38k - $145k
At Recor Medical, we are pioneering Ultrasound Renal... ...treat hypertension, the leading cardiovascular risk... ...focus on packaging and labeling activities. This position... ...design outputs and compliance with change control processes... ...such as the medical device industry. 5 years of...Medical deviceContract work- ...seeking a Senior Regulatory Affairs Program Lead in Santa Clara, CA. This role involves... ...instruments and accessories, ensuring compliance with US and international regulations.... ...in regulatory affairs within medical devices, strong analytical skills, and excellent...Medical device
- ...accordance with FDA QMSR and ISO standards. Lead preparation and... ...and ongoing compliance, including complaint... ...compliance with FDA MDR and device vigilance reporting regulations... ...of Moximed Medical Device Reports (MDRs)... ...promo review of product labeling, literature and...Medical deviceFlexible hours
- ...Campbell, California. This role is crucial in ensuring compliance with regulatory standards and leading quality-focused initiatives across product... ...strong background in Quality and Design Assurance in medical devices, a Bachelor’s degree in Engineering, and demonstrated...Medical device
- ...crucial in overseeing all document control activities in compliance with FDA/QSR/QMSR and ISO 13485 standards. You'll be instrumental in developing... ...of experience as a Document Control manager in the Medical Device industry, alongside strong leadership and problem-solving...Medical device
- System One is seeking a Regulatory Affairs Specialist IV in Sunnyvale, CA, to lead regulatory strategy and submissions for medical devices across the U.S., Canada, and global markets. This 6‑month contract role requires deep regulatory expertise and strong cross‑functional...Medical deviceContract work
$114k - $130k
...fast-growing, publicly traded medical device company that is an industry pioneer... ...to manufacture, package and label the company’s products. In the event of potential non‑compliance with applicable standards or regulations (e.g. FDA QSRs, ISO 13485, or ISO 14971), the...Medical deviceContract workLocal area$81.5k - $141.3k
...organization to maintain regulatory compliance for a portfolio of endovascular medical devices used in the treatment of... ...manufacturing, supplier, process, and labeling changes to determine regulatory impact... ...standards, including ISO 13485, and ISO 14971. Experience...Medical deviceFor contractors
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