Senior Medical Device Regulatory Lead - Submissions
$90k - $180kAbbott
Abbott is seeking a Senior Regulatory Affairs Specialist in Santa Clara, CA to provide regulatory input across the product lifecycle and support compliance with various regulations. The ideal candidate will possess 3–4 years of experience in a regulated industry and strong communication skills. This role offers a competitive salary range from $90,000 to $180,000 and excellent benefits including medical coverage, retirement savings plans, and educational reimbursements. #J-18808-Ljbffr Abbott
- ...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...SeniorRegulatoryMedical device
- A leading staffing company is seeking an experienced regulatory professional for their Companion Diagnostics team. The ideal candidate will have... ...regulatory experience in IVDs and medical devices, leading successful submissions and working directly with regulatory bodies...SeniorRegulatoryMedical device
- ...and drives a vibrant regulatory culture, working among... ...access Write and file FDA submissions (e.g., Q-submissions,... ...for specifications, device testing, risk... ...Affairs experience within Medical Device is required (4+... ...skills with the ability to lead multiple projects/...SeniorRegulatoryMedical device
$109k - $174.8k
...States of America Position Senior Regulatory Affairs Program Lead - Instrumentation &... ...development stages, generate submission‑ready documentation, and... ...feedback for specifications, device testing, risk management,... ...experience within Medical Device (4+ years with Advanced...SeniorRegulatoryMedical deviceLocal areaImmediate start- Johnson & Johnson MedTech is seeking a Senior Regulatory Affairs Program Lead in Santa Clara, CA. This role involves leading regulatory strategies... ...6 years of experience in regulatory affairs within medical devices, strong analytical skills, and excellent communication...SeniorRegulatoryMedical device
$146.3k - $244.1k
A leading technology company in Cupertino is seeking a Senior Lead Auditor to support their healthcare product line. In this... ...to ensure compliance with regulatory standards. Ideally, candidates... ...benefits such as stock options, medical coverage, and educational reimbursements...SeniorRegulatoryMedical device$146.3k - $244.1k
...together, committing to the values that lead to great work. Every new product... ...Health group is looking for a Senior Lead Auditor to support regulated medical device features. If you are passionate... ...audit program to ensure ongoing regulatory compliance and encourage continuous...SeniorRegulatoryMedical deviceRelocation- ...developing Dragonfly, a portable microwave-based brain scanner for rapid stroke detection at the point of care. We're looking for a Senior Regulatory Affairs Specialist to own our global regulatory strategy and drive Dragonfly through FDA clearance and international market...SeniorRegulatoryMedical device
- Imperative Care is seeking a Senior Manager in Design Assurance located in Campbell... ...in ensuring compliance with regulatory standards and leading quality-focused initiatives across... ...in Quality and Design Assurance in medical devices, a Bachelor’s degree in Engineering...SeniorRegulatoryMedical device
- ...Campbell, California, is looking for a Senior Manager to lead Design Assurance initiatives. This... ...decision making and ensuring regulatory compliance in product development. The... ...will have significant experience in medical device quality assurance, supporting new product...SeniorRegulatoryMedical device
- ...Solutions Services, LLC in Sunnyvale, CA is seeking a Sr. Regulatory Affairs professional with over 8 years of experience in medical devices. This role involves developing regulatory plans, preparing submissions, and ensuring compliance with U.S. and Canadian regulations...SeniorRegulatoryMedical device
- BBG Ventures, LLC is seeking a Senior Regulatory Affairs Specialist to join their team in Sunnyvale... ...regulatory affairs experience in the medical device sector and a strong understanding of... ...regulatory guidance, preparing submissions, and ensuring compliance with industry...SeniorRegulatoryMedical deviceFor contractorsRemote work
- ...interventional catheter device design, development,... ...highly motivated, hands‑on Senior Medical Device R&D Engineer to... ...and Responsibilities Lead technical projects... ...manufacturing, quality, regulatory, and leadership teams... ...Body regulatory submissions Experience using cloud...SeniorRegulatoryMedical deviceLocal areaRelocationVisa sponsorship
- ...Stryker is hiring a Senior Regulatory Affairs Specialist to support Sports... ...lifecycle, manage regulatory submissions, advise stakeholders on... ...product claims. Evaluate proposed device modifications to determine... ...a regulated industry (e.g., medical devices, IVDs, pharmaceuticals...SeniorRegulatoryMedical deviceTemporary workLocal areaFlexible hours
- ...reports to Manger/Sr. Manager, Medical Sciences and requires a... ...essential requirements in support of submission for CE Mark application to... ..., product development, regulatory, post‑market surveillance) to... ...therapeutic areas, competitor devices, current clinical/market developments...SeniorRegulatoryMedical deviceLocal areaWorldwideShift work
$214k - $356.6k
International Regulatory Affairs Lead (Medical Devices) Cupertino, California, United States Hardware The Health group is looking for an International... ...complex information into geo-specific filings, submissions, slides and other communication formats. Execute complex...RegulatoryMedical deviceRelocation$90k - $180k
Senior Regulatory Affairs Specialist - Santa Clara, CA This onsite position... ...Determine and communicate submission and approval requirements.... ...Employees qualify for free medical coverage under the Health Investment... ...working in the medical device industry. Certification is...SeniorRegulatoryMedical deviceWork experience placement$90k - $180k
Abbott Laboratories is seeking a Senior Regulatory Affairs Specialist at their Santa Clara, CA location. This role involves supporting the... ...providing regulatory input for product lifecycles and handling submissions to regulatory authorities. The ideal candidate should have a...SeniorRegulatory$90k - $180k
...spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...and peripheral stents. Senior Regulatory Affairs Specialist This onsite... .... Determine and communicate submission and approval requirements. Participate...SeniorRegulatoryMedical deviceWork experience placementWorldwide- ...Inc. in Cupertino, California is 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...RegulatoryMedical device
- A leading staffing firm is seeking a seasoned medical device engineer in Sunnyvale, California. The ideal candidate will possess over 10 years of experience in... ...during clinical testing, and ensuring compliance with regulatory requirements. Strong communication and leadership...RegulatoryMedical deviceLocal area
- ...approach. Working with top medical professionals, they... ...worldwide. Position Senior Regulatory Affairs Specialist (Contract... .... Influence and lead global regulatory strategies... ...documentation and submissions, including FDA 510(k)... ...in a medical device environment. Strong understanding...SeniorRegulatoryMedical deviceContract workFor contractorsRemote workWorldwide2 days per week
- ...searching for an experienced regulatory professional to work within... ...experience working in IVD, Medical Devices, or Pharmaceuticals, with a... ...of successful regulatory submissions, registrations, 510(k)’s, and... ...in regulatory affairs leading to the successful regulatory...SeniorRegulatoryMedical device
- Shockwave Medical is seeking a dedicated Senior Quality Engineer in Santa Clara, CA, to provide Design Quality Assurance for medical device designs and ensure compliance with industry regulations... ...include process improvements, regulatory documentation, and enhancing quality...SeniorRegulatoryMedical device
$173k - $192k
...Campbell, California, requiring expertise in risk management and regulatory standards. The ideal candidate will possess a BS in Engineering... ...regulated industries, focusing on catheter and neurological device development. Employee benefits include stock options, health benefits...SeniorRegulatoryMedical deviceFull time$97.6k - $140.4k
A global medical device company is seeking a Post Market Clinical Follow up Specialist to lead and execute PMCF strategies. The successful candidate will manage cross-functional teams, ensuring compliance with regulatory requirements. This role requires a strong background...RegulatoryMedical device$170.5k - $245.3k
Intuitive Surgical, Inc. seeks a Senior Project Manager for their PMO to lead cross-functional teams driving new product development in the Cardiac market... ...ideal candidate will have 8+ years experience in medical devices and possess strong project management skills. The...SeniorMedical device- Intuitive is looking for a Senior Project Manager, PMO in Sunnyvale, California. The role involves leading cross-functional teams to deliver innovative medical device products with a focus on project management and strategic alignment. Candidates should possess a BS degree...SeniorMedical device
- ...Senior Managing Counsel, Privacy & Cybersecurity About the... ...compliance. Industry Medical Devices Type Privately Held... ...Privacy and Cybersecurity to lead the legal support for these... ...compliance with contractual and regulatory obligations, and managing legal...SeniorRegulatoryMedical device
- ...associated with human subjects. Lead data processing and analysis. Lead authorship and submissions of abstracts, white papers,... ...electro‑mechanical medical device. Experience with authoring and... ...commercial, clinical engineering, and regulatory. Excellent collaboration...SeniorRegulatoryMedical deviceWork at officeWorldwideShift work
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