Senior Regulatory Director, Medical Devices & FDA Submissions
EPM Scientific
EPM Scientific in the San Jose Bay Area is seeking a Director of Regulatory Affairs to lead regulatory strategy for innovative endoscopy, medical imaging, and AI-driven diagnostics. This onsite/hybrid role offers direct FDA interaction, cross-functional collaboration, and impact on product submissions while shaping the company’s regulatory roadmap. You will oversee premarket activities, submissions (510(k) familiarity), risk management, and quality systems alignment with ISO 13485, contributing #J-18808-Ljbffr EPM Scientific
- ...Imperative Care is seeking a Senior Supplier Quality Manager to lead the Supplier Quality... ...will ensure compliance with ISO 13485, FDA regulations, and governing standards... ...requires 8+ years in supplier quality within medical devices, supervisory experience, and strong...SeniorMedical deviceContract work
- ...SummaryThe Sr. Manager, Regulatory Affairs for the... ...including software as a medical device (SaMD), software in a... ...professionals and serves as the senior regulatory voice to... ...'s regulatory status.Submissions and Market... ...Lead interactions with FDA including pre-submission...SeniorMedical deviceLocal areaWorldwideFlexible hours
- ...based in Mountain View, CA, seeks a Senior Regulatory Affairs Manager to lead regulatory support... ...for a fully implantable US Class III medical device system. This hybrid role requires... ...will supervise regulatory staff, drive submissions (PMA/IDE), and ensure compliance...SeniorMedical deviceWork at office
$130.7k - $261.3k
...and products in diagnostics, medical devices, nutritionals and branded... ...Opportunity We are recruiting for a Senior Regulatory Affairs Manager to join our... ...for compiling regulatory submissions and ensure data is... ...and market access.Support FDA, EU MDR/CE Mark, and other...SeniorMedical deviceWork experience placementWorldwideShift work$163.3k - $290.1k
...Senior Regulatory Engineering Program Manager - Smarter Chemistry Imagine what you could do here at Apple, new ideas have a way of becoming... ...or MBA preferred, but not required Working knowledge of medical device hardware, testing, and manufacturing processes Technical...SeniorMedical deviceRelocationFlexible hours- Director of Regulatory Affairs Supporting innovative endoscopy... ...a growth-stage medical technology... ...direct exposure to FDA interactions, this... ...data for regulatory submissions. Support the... ...Provide assistance to senior regulatory... ...knowledge of medical device regulatory requirements...Medical device
$160k - $190k
...NeuroPace is a commercial-stage medical device company focused on... ...We are currently seeking a Senior Regulatory Affairs Manager to join our... ...study projects and related submissions for a highly technical and... ...extensive experience with FDA regulations; PMA experience...SeniorMedical deviceWork at office2 days per week3 days per week$112k - $152k
...Outset, a trailblazing medical device company that is... ...complexity of dialysis. FDA cleared for use across... ...Position Overview The Senior Microbiologist will serve... ...compliance with applicable regulatory and quality... ...assessments, and regulatory submission content. Evaluate microbiological...SeniorMedical deviceContract workLocal areaImmediate start- Intuitive Surgical, Inc. seeks a Senior Project Manager to lead the full lifecycle of medical device endoscope development from... ...commercial launch. You will steward regulatory, sterilization,... ...with rigor, while aligning with FDA/EU MDR/ISO standards and #J-18...SeniorMedical device
- ...distribution of Imperative Care’s medical device products consistent with the... ...that adhere to ISO 13485, FDA, and other governmental... ...projects Ensure compliance to regulatory requirements. Uphold quality... ...or future positions. Submission of unsolicited resumes in advance...SeniorMedical deviceFull timeContract workWork experience placement
- ...Intuitive Surgical seeks a Senior Manager of Regulatory Affairs to lead... ...execution for software-driven medical products, including... ...roadmaps Determine device classification, qualification, and submission pathways for software... ...submissions to FDA Guide regulatory strategy...SeniorMedical device
- Akura Medical, a Shifamed portfolio company, seeks a Senior Process Development Engineer to design and develop processes for catheter, nitinol and console manufacturing... ..., equipment selection, supplier management, and support for regulatory activities. #J-18808-Ljbffr Akura MedicalSeniorMedical device
- Supira Medical, a clinical-stage Shifamed portfolio company, seeks a Sr. Director, Clinical Affairs to own the IDE pivotal... ...will partner with R&D, Regulatory, Quality, and Marketing,... ...has 15+ years in medical device clinical research, deep FDA/ISO knowledge, and leadership...SeniorMedical device
- ...Senior Systems Engineer This Senior Systems Engineer... ...to develop and maintain medical device products, according to customer... ...requirements, applicable regulatory and quality standards.... ...Systems Engineers; Support FDA and other regulatory submission and audits; Who you...SeniorMedical device
- ...is seeking a highly motivated Principal Regulatory Affairs Specialist to join our Vascular... ...lead global regulatory strategies, prepare submissions (510(k)s, PMAs), and collaborate with... ...regulatory assessments, communications with FDA and Notified Bodies, and ensuring...SeniorMedical device
- ...shaping product messaging and sales enablement tools for accelerated market adoption. The ideal candidate will bring 8+ years in medical device or pharmaceutical marketing, strong leadership, and a track record of cross-functional collaboration across product, sales, and...SeniorMedical device
- ...company in California is looking for a Principal Regulatory Affairs Specialist to spearhead complex regulatory strategies for Class III devices. This role involves authoring PMA submissions, ensuring compliance for medical devices, and mentoring junior staff. Strong...SeniorMedical device
- ...Intuitive Surgical seeks a senior quality engineer to lead design controls, risk management, and regulatory compliance for next-generation surgical systems... ..., manufacturing transfer, and FDA submissions across complex medical devices. Responsibilities Plan and execute...SeniorMedical device
- ...on-site, full-time role involves leading cross-functional teams across marketing, engineering, and sales to launch and optimize medical devices. The candidate brings 8+ years in medical device product management, strong leadership, and excellent communication. Travel up...SeniorMedical deviceFull time
- Intuitive Surgical in Sunnyvale, CA seeks a Senior Program Manager to lead the full lifecycle of medical device capital systems from concept to launch. You will drive cross-functional teams, ensure regulatory compliance (FDA, EU MDR, ISO 13485), and coordinate manufacturing...SeniorMedical device
- ...through late-stage development toward regulatory submission.The ideal candidate will bring deep expertise... ...(IRs) from health authorities (FDA, EMA) regarding analytical topics.Ensure... ...: Full-timeFunction: Public RelationsExperience level: AssociateIndustry: Medical DeviceSeniorMedical deviceContract workLocal areaWorldwideFlexible hours
- Enlil, a Shifamed portfolio company, is seeking a Senior Account Executive to cover the Minnesota MedTech market. You will identify... ...years of strategic account sales, preferably in SaaS or PLM, with medical device experience and a strong Minnesota network. You will maintain a...SeniorMedical device
- Abbott is seeking a Senior Medical Writer / Senior Project Manager, Clinical Evaluation, to join the Vascular... ...evaluation expertise with project leadership to support regulatory submissions and CE marking efforts for medical devices. You will develop clinical evaluation plans and...SeniorMedical device
- Imperative Care is seeking a Senior Manager of Marketing who will lead staff in delivering commercial marketing strategies, tools, and programs designed to expand market share for current and future products. The role focuses on engaging customers through training, materials...SeniorMedical device
- ...early-stage, pre-commercial medical device company with a vision for... ...DeepSight Technology is seeking a Senior Systems Engineer with a... ...robust, traceable, and regulatory-compliant test solutions.... ...) Experience supporting FDA submissions and regulatory audits Ability...SeniorMedical device
$120k - $140k
A leading medical device company is hiring a Senior Clinical Research Associate (Field) in the Los Gatos area. This full-time remote role involves monitoring clinical trial sites and ensuring compliance with regulations. Applicants should have a Bachelor's degree in life...SeniorMedical deviceRemote jobFull time- Job DescriptionTitle: Senior Software Architect EngineerType: permanentLocation... ...Jose, CAJob description:A Medical Device Company Located in San Jose,... ...required technical and regulatory documentation.• Produces and... ...design controls, and 510(k) submissions is a plus.• Good...SeniorMedical devicePermanent employment
$235k - $260k
...please visit grail.com As Senior Corporate Counsel/ Associate Director, Compliance, you will... ...leaders across Commercial, Medical Affairs, Clinical,... ...initiatives, balancing legal and regulatory requirements with... ...pharmaceutical, medical device, or other life sciences...SeniorMedical deviceFull timeWork at officeLocal areaWorldwideFlexible hours- ...drive clinical evidence generation for product development, regulatory submissions, and commercial growth. You will translate data into publications... ...manuscripts, manage the publication pipeline, and support FDA submissions while ensuring scientific integrity and...SeniorMedical device
$103.5k - $142.5k
...everything possible.The Senior Field Actions... ...worldwide regulatory requirements and... ...position reports to the Director, Adverse Events... ...evaluations, regulatory submissions, customer... ...Experience within the medical device, in vitro... ...Working knowledge of FDA Quality Management...SeniorMedical deviceFull timeImmediate startWorldwide
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