Senior Regulatory Leads - Medical Devices & FDA Submissions
CorDx
CorDx is seeking a Senior Regulatory Affairs Manager to oversee regulatory submissions for medical device products. This role requires a Master's degree and 7-10 years of experience in regulatory affairs, specifically within the medical device industry. The Manager will ensure compliance with FDA regulations while guiding cross-functional teams through the regulatory landscape. Located in San Diego or Atlanta, this position offers a highly competitive compensation package and comprehensive benefits including medical, dental, and vision coverage. #J-18808-Ljbffr CorDx
- Sobi in San Diego is seeking a Principal Medical Writer who will lead the authoring of clinical and regulatory documents. This role requires 8-10 years of experience, focusing on clarity and credibility in submissions to fulfill regulatory needs. The ideal candidate will...SeniorRegulatory
- Jobtailor in San Diego seeks a Senior Medical Writer with oncology focus to provide strategic... ...writing for complex clinical and regulatory documents. You will lead authoring and end-to-end development for health authority submissions. Requirements include a PhD preferred...SeniorRegulatory
- ...Therapeutics in San Diego is looking for an Associate Director, Medical Writing to oversee regulatory submissions and manage related documentation. This role requires... ...or PharmD is preferred. The Associate Director will lead a team of medical writers, ensuring high-quality...SeniorRegulatoryRemote job
$90k - $150k
...rapid testing and point-of-care medical device solutions used in the... ...in healthcare. Position: Senior BD Manager Location: Onsite... ...with internal stakeholders in Regulatory, Finance, and Operations to support... ...with regulatory frameworks (FDA, ISO 13485) and intellectual...SeniorRegulatoryMedical deviceContract workFlexible hoursShift work$68k - $102k
Worklane GmbH is seeking a Quality Assurance professional to ensure compliance with regulatory frameworks and enhance product quality. The candidate will support audits and manage quality projects, interacting with various stakeholders. Required qualifications include...SeniorRegulatoryMedical device$119k - $156k
...openness. We are seeking an experienced Senior Lead, Enterprise Master Data who will play... ...3485), supporting audit readiness and regulatory requirements Standardize customer... ...Business Systems (biotech, pharma, or medical device experience preferred) Strong working...SeniorRegulatoryMedical deviceFull timeFlexible hours- ...Senior Software Engineer Research & Development... ...to a dedicated medical device software team... ...iterative and subject to regulatory, technical, and... ...Act as a technical lead for a team,... ...activities for regulatory submissions, collaborating... ...regulatory teams during FDA submissions and...SeniorRegulatoryMedical device
$68k - $102k
...compliance, multiple regulatory frameworks and to support... ...applicable to medical devices for the markets in which... ...Drug Administration (FDA) in the United States... ...management review prior to submission. Recommend opportunities... .... Acting as lead or experienced supporting...RegulatoryMedical deviceTemporary workWork experience placementFlexible hours- ...Associate Director, Senior Technical Writer is... ...for Class II medical devices. This role combines... ...candidate brings extensive regulatory experience,... ...and the ability to lead a high‑performing team... ...global regulatory submissions. Ensure compliance with FDA, EU MDR, ISO 13485,...RegulatoryMedical deviceFor contractorsWork at officeRemote work
- ...Scrum Master - PMO -[FDA, Healthcare,PMP... ...Shift Client : Medical Devices Company Job... ...of Experience : Senior Level Employment... ...projects. This position leads the planning and... ..., R&D, Clinical, Regulatory Affairs, Quality,... ...FDA), regulatory submission and product...RegulatoryMedical deviceContract workDay shift
$220.6k - $275.7k
...includes the first and only FDA‑approved treatments... ...Position Summary The Senior Director, Regulatory Operations provides... ...electronic submissions, regulatory information... ...Primary Responsibilities Lead and scale the global... ...ongoing equity packages Medical, dental, and vision...SeniorRegulatoryWork at officeLocal areaRemote workWorldwideNight shift3 days per week$230.9k - $288.6k
...the first and only FDA-approved treatments... ...Position Summary The (Senior) Director, Clinical... ...network in the medical community, and successful... ...experience in leading clinical programs.... ...stakeholders. Support regulatory interactions, including the submission of regulatory...SeniorRegulatoryWork at officeLocal areaRemote workNight shift$168k - $183k
...technology, which has received FDA clearance, is designed... ..., data analysis, regulatory submissions, and product... ...as: Generous Benefits (Medical/Dental/Vision/EAP/Paid... ...platform resources. Lead root cause investigations... ...experience in IVD, medical device, or diagnostic...RegulatoryMedical deviceLocal areaImmediate startFlexible hours- ...Senior Managing Counsel, Privacy & Cybersecurity About the... ...compliance. Industry Medical Devices Type Privately... ...Privacy and Cybersecurity to lead the legal support for these... ...compliance with contractual and regulatory obligations, and managing...SeniorRegulatoryMedical device
- Pfizer is seeking a Global Development Lead based in San Diego, CA, to oversee clinical development for internal medicine assets... ...functional teams to execute clinical studies from design to regulatory submission. The ideal candidate will have an MD or DO with over 8 years...SeniorRegulatory
- ...is seeking a Quality Engineer to maintain and improve the quality systems in line with MDSAP, ISO, FDA, and QSR requirements. This role supports regulatory submissions and ongoing product quality improvements across design, development, and manufacturing processes. The...RegulatoryMedical device
$210k - $240k
Senior Director, Regulatory Affairs-CA Requisition ID: 1032 Salary... ...‑related submissions, working closely... ...and Submissions Lead regulatory strategy... ...submissions to the FDA; support additional... ...for complex BCI devices, including AI/ML... ...firmware‑driven medical technologies Ensure...SeniorRegulatoryMedical deviceFull timeFlexible hours- A leading medical device company is seeking a Staff Process Engineer (Hardware) for a remote position based in San Diego, CA. The role involves... ...hardware design processes while ensuring compliance with regulatory standards. The ideal candidate should have at least 5 years...SeniorRegulatoryMedical deviceRemote jobContract work
- ...and point-of-care medical device solutions used in... ...time Job Title: Senior Project Manager Location... ...Manager to lead and support cross-... ...company strategy and regulatory requirements. The... ...Support regulatory submission readiness... ...standards (e.g., FDA, ISO 13485). Facilitate...SeniorRegulatoryMedical deviceFull timeFlexible hoursShift work
$219k - $273.7k
...includes the first and only FDA‑approved treatments for Parkinson... .... This individual will lead the design, implementation,... ...therapies for patients with unmet medical needs. Primary... ...datasets supporting analysis, regulatory submissions and health‑authority inspections...SeniorRegulatoryContract workWork at officeLocal areaRemote workNight shift3 days per week$132k - $172k
Travere Therapeutics in San Diego is seeking a Senior Manager, Medical Writing to oversee the authoring and management of regulatory, clinical, and safety documents. This role requires leadership in document strategy and adherence to compliance while working closely with...SeniorRegulatory- Position: Senior Project Manager Location: Preferred... ...Hours/week: 40.00 Client: Medical Device Company Employment... ...Qualifications Must Haves 5+ years leading global cross‑functional... .... Experience in regulatory assessment processes and document submission. Business Change...SeniorRegulatoryMedical deviceContract workH1b
$100k - $130k
...preventive actions (CAPA). Lead and participate in internal... ...industry best practices and regulatory requirements. Requirements... ...Thorough knowledge of US FDA 21 CFR 820 Quality System Regulation... ...and practices in the medical device industry. Excellent communication...RegulatoryMedical device- ...Corporation is looking for a Director of Regulatory Affairs to lead regulatory strategy and... ...position involves coordination with FDA and overseeing regulatory submissions in the pharma/biotech field.... ...regulatory strategies. Benefits include medical and dental insurance, vacation...RegulatoryRemote job
- ...for a Software Engineer specializing in Medical Device Development. This role involves... ...processes and documentation in compliance with regulatory standards. The ideal candidate should... ...software engineering or medical devices. Lead multi-disciplinary teams and contribute...SeniorRegulatoryMedical deviceRemote job
- Dexcom is seeking a Senior Staff Technical Program Manager for Sensor Technology to bridge IVST and R&D, guiding... ...You will partner with the Sensor Technology System Lead to drive cross-functional execution and regulatory compliance. You will manage design controls, risk,...SeniorRegulatoryMedical device
$125k - $145k
...for the Complaint department in San Diego, responsible for leading investigations and ensuring compliance with regulatory requirements. The ideal candidate will have extensive experience in the medical device or biotech industry, a strong background in complaint management...SeniorRegulatoryMedical device- BioTalent is seeking a Senior Quality Engineer in San Diego to own and improve the QMS... ...processes across the organization. You will lead design controls with R&D, clinical, and... ...support audits and inspections for a medical device manufacturing environment. #J-18808-Ljbffr...SeniorMedical device
$120k
...Bionics Clinical Affairs Lead Beta Bionics, Inc. is a medical technology company dedicated... ...clinical operations and regulatory teams in the set up and... ...providers and patients use the device commercially. Support... ...as needed for regulatory submissions Assist in the preparation...RegulatoryMedical deviceWork at officeLocal area2 days per week3 days per week- A leading medical devices company in San Diego is seeking a Senior Staff Quality Engineer to lead projects aimed at improving quality compliance in the dispensing implementation... ...and at least 10 years of experience in FDA regulated environments. Strong knowledge of...SeniorMedical deviceContract work
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