Senior Regulatory Operations Lead — Medical Devices
Alcon Laboratories
Alcon in Fort Worth, TX and Lake Forest, CA, seeks a Sr. Manager, Regulatory Operations to direct product submissions, ensure timely regulatory approvals, and align global strategies to maximize product value in medical devices and pharmaceuticals. You will oversee dossier preparation, Clinical Trial Disclosure, submission publishing, licensing and labeling, lead cross‑functional teams, ensure GxP compliance, implement process improvements, and mentor staff in a fast‑paced, regulated environment. #J-18808-Ljbffr Alcon
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Operations Lead — Medical Devices in Lake Forest, CA vacancy
$105k - $120k
...is an ophthalmic medical technology corporation... ...eye.OVERVIEW:The Senior Quality Engineer I... ...to successfully operate in a highly dynamic... ...will include leading and documenting investigations... ...to applicable regulatory requirements.In... ...’s) for medical devices. The Senior Quality...SeniorRegulatoryMedical device- ...leaders to design secure, scalable solutions for a regulated medical device business. You will provide technical leadership across cloud... ...initiatives, and software development, ensuring alignment with regulatory requirements and enterprise standards. #J-18808-Ljbffr STAAR...SeniorRegulatoryMedical device
$135k - $165k
...Compliance Quest workflows to ensure regulatory compliance, audit readiness, and uninterrupted business operations. Supports Sales Cloud users... ...functional documentation. Leads and participates in testing... ...in a regulated industry (medical device, pharmaceutical, or life...SeniorRegulatoryMedical deviceInternational Executive Service Corps
Lake Forest, CA1 day ago- Applied Medical in California seeks a Business Analyst - SAP SuccessFactors to optimize HR operations across Employee Central, Recruiting, Onboarding... ...on data integrity, regulatory compliance, and scalable HR... ...opportunities in a growing medical device company. #J-18808-Ljbffr...SeniorRegulatoryMedical device
- ...partners to deliver secure, scalable solutions in a regulated medical device environment. You will provide technical leadership for... ...initiatives, and software development, ensuring alignment with regulatory requirements and #J-18808-Ljbffr International Executive Service...SeniorRegulatoryMedical device
$100k - $120k
Applied Medical is a new-generation medical device company with a proven business model and... ...DescriptionThe senior machine design engineer, automation leads the design and development... ...documentation and designs meet regulatory, quality, and operational standards.Driving...SeniorRegulatoryMedical deviceLocal area- ...Senior Quality EngineerPassionate about precision... ...Quality Engineer, you will:Lead verification,... ...systems supporting Tempus Medical Device(s).Lead risk assessments... ...guidance, other applicable regulatory requirements, as well... ...of the host system operating with Tempus Medical...SeniorRegulatoryMedical deviceWork at office3 days per week
Tempus
Aliso Viejo, CA1 day ago $107k - $150k
Applied Medical is a new generation medical device company with a proven business... ...Position DescriptionA Senior Engineer,... ...functional teams, they lead database-related initiatives... ....Automates operational processes to improve... ...auditing, compliance, and regulatory requirements such...SeniorRegulatoryMedical deviceLocal area- ...this role, a typical day will include: Operational support / execution tasks associated... ...conduct independent research within the Regulatory Affairs Strategy team to optimize... ...drive competitive advantage Support medical device and/or pharmaceutical products, ensuring...SeniorRegulatoryMedical deviceHourly payTemporary workRelocation packageFlexible hours
- ...We are seeking a highly motivated Senior R&D Project Engineer to lead Cost Improvement Projects (CIP), design... ...activities within a regulated medical device environment. The ideal candidate... ...device product development experience, regulatory knowledge, and the ability to...SeniorRegulatoryMedical deviceRemote work
$190k - $270k
...advisor role within a global, publicly-traded medical device company.You will work directly with senior leadership and support the board of directors,... ...Functional Legal Leadership: Support commercial operations, regulatory and health care compliance programs, and enterprise...SeniorRegulatoryMedical deviceShift work$95.8k - $159.6k
...Flexibility: Hybrid or OnsiteSenior International Regulatory Affairs SpecialistIrvine, CAJoin a team focused on bringing medical technologies to market while ensuring... ...interactions.Experience working with medical devices or other regulated healthcare products.$95,80...SeniorRegulatoryMedical deviceFull timeFor contractorsLocal area$89.4k - $148.9k
...the ongoing manufacturing of medical devices by designing, documenting, and... ...manufacturing processes and operations that ensure product safety, quality, and performance.Lead process qualification, verification... ...manufacturing operations and regulatory compliance.Analyze,...SeniorRegulatoryMedical deviceFull timeFor contractors- ...serving the Pharmaceutical, Medical Device, Biotech, and IT... ...Quality & Validation, Regulatory Affairs, R&D, Manufacturing... ...that drive growth, operational excellence, and long-... .... Position: Senior Supplier Quality Engineer... ...DFM requirements. Lead mold design reviews with...SeniorRegulatoryMedical device
Stark Pharma Solutions Inc
Irvine, CA4 days ago $120k - $150k
...Senior Electrical Design EngineerThe Senior Electrical Design... ...electronic systems for critical care medical devices. This role supports... ...production and service departments.Lead initiatives that support... ...with ISO, IEC, and FDA regulatory requirements for 510K submissions...SeniorRegulatoryMedical deviceWork at officeNIHON KOHDEN OrangeMed
Orange, CA1 day ago$89.4k - $148.9k
...OnsiteStryker is hiring a Senior Quality Engineer for... ...across manufacturing operations, products, and... ...quality performance. Lead and support initiatives... ...compliance with applicable regulatory requirements, industry... ...relatedExperience in the medical device industry with...SeniorRegulatoryMedical deviceFull timeFor contractorsWork at office$95k
...Senior Associate, Clinical ResearchIrvine, CA, Corporate OfficeOverviewSalary... ...ensure compliance with all regulatory requirements. The ideal... ...dates).Provide clinical operational support during preparation... ...is required (preferred in medical devices).Advanced degree in a biological...SeniorRegulatoryMedical deviceFull timeLocal areaJenaValve Technology, Inc.
Irvine, CA2 days ago$130k - $165k
...partner with Quality Assurance, Regulatory Affairs, Manufacturing, Supplier Quality, Operations, and IT to design, implement,... ...system compliance in a regulated medical device environment.Essential Functions... ...business requirements. • Lead business process workshops and...SeniorRegulatoryMedical device- ...ophthalmic pharmaceutical and medical technology company... ...and local regulations.Senior Scientist / Senior... ...clinical dose selection, and regulatory submissions.The... ...technologies, medical devices, and combination products... ...support candidate selection, lead optimization, IND-...SeniorRegulatoryMedical deviceLocal areaFlexible hours
$118k - $196.6k
Work Flexibility: OnsiteAs a Senior Staff R&D Systems Engineer, you will serve as a leading member of the R&D team for our... ...platforms. This role bridges advanced medical device hardware with high-performance... ...R&D, Quality, Manufacturing, Regulatory, and Clinical teams to ensure...SeniorRegulatoryMedical deviceFull timeFor contractorsWork experience placement- ...Senior Software Engineer - Android OS for a CONTRACT to HIRE role in Irvine... ...a customized Android 5-based operating system used within a Class III medical device. You will customize and harden... ...medical-device cybersecurity and regulatory requirements. This role...SeniorRegulatoryMedical deviceContract work
3B Staffing LLC
Irvine, CA5 days ago $25 per hour
...company in the world to focus solely on medical device materials for safety. NAMSA started... ...accordance with criteria outlined in Standard Operating Procedures. May be required to operate... ...Laboratory Science, Clinical Research, Regulatory Affairs, Quality Assurance, Engineering...SeniorRegulatoryMedical deviceLocal areaNorth American Science Associates, Inc.
Irvine, CA3 days ago- The Senior Scientist, R&D Chemistry, works... ...sterilization of medical instruments.Demonstrates... ..., quality, and regulatory expectations.... ...Experience in the Medical Device or other GxP-... ...chemistry.Experience in leading R&D Chemistry... ...per ASP standard operating procedures.Supports...SeniorRegulatoryMedical deviceLocal area
$89.4k - $148.9k
...on delivering high-quality medical devices through robust manufacturing... ...will support manufacturing operations by applying engineering principles... ..., product quality, and regulatory compliance. This position offers... ..., or process performance.Lead and document engineering tests...SeniorRegulatoryMedical deviceFull timeFor contractorsWork at officeMonday to FridayAfternoon shift$150k - $165k
...- $165,000.00/yr The Senior Quality Systems Manager... ...regulations. This role also leads and develops the... ...functionally to support operations, engineering, and... ...Our client is a global medical device manufacturer focused on... ...ensuring compliance with regulatory and ISO requirements....SeniorRegulatoryMedical deviceFull timeLocal areaMichael Page
Irvine, CA5 days ago$110k - $130k
...Senior Manufacturing Test Engineer The Senior Manufacturing... ...Test Engineer leads the development,... ...across manufacturing operations. $110k - $130k Direct... ...Ensure compliance with regulatory standards (FDA, ISO 13... ...manufacturing integration Medical device or highly regulated...SeniorRegulatoryMedical deviceMarquee
Irvine, CA2 days ago- ...Senior Electrical EngineerOur client, a medical device and healthcare company, is looking for a Senior Electrical Engineer for their Irvine... ...Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task...SeniorRegulatoryMedical deviceFor contractorsWork experience placement
ICONMA
Irvine, CA3 days ago $173k - $245k
..., we’re committed to operating with honesty, openness... ...Lifesciences is the leading global structural heart... ...patient needs. Our Senior Director, Global Compliance... ...excellence and regulatory adherence. Oversight... ...Compliance in a large Medical Device, Pharmaceutical, and/...SeniorRegulatoryMedical deviceFull timeWork experience placementLocal area$200k - $300k
...Artificial Intelligence is responsible for leading the Company's enterprise... ..., Engineering, Quality Assurance, Regulatory Affairs, Commercial Operations, Finance, Human Resources, Cybersecurity... ...transformation.• FDA-regulated medical devices, biotechnology, pharmaceutical,...SeniorRegulatoryMedical device$76.5k - $117.1k
...gather and consolidate demand inputs, regulatory approval timeline, sales order, financial... ...trends and historical sales data. Lead/Facilitate OUS Executive Demand Plan Review... ...Proficiency in SQL and PowerBI. Medical device background. ASCM, Six Sigma or Supply...SeniorRegulatoryMedical deviceFull timeStryker
Irvine, CA29 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Operations Lead — Medical Devices. Be the first to apply!
Related searches
- senior network engineer remote Lake Forest, CA
- senior manager legal Lake Forest, CA
- senior commercial counsel Lake Forest, CA
- senior manager tax Lake Forest, CA
- senior living Lake Forest, CA
- senior implementation project manager Lake Forest, CA
- senior level Lake Forest, CA
- senior consulting engineer Lake Forest, CA
- senior human factors engineer Lake Forest, CA
- senior resident engineer Lake Forest, CA