Regulatory Bioengineer - Medical Devices FDA 510(k) Lead
$60k - $80kInflammaSense
An innovative medical device company in California seeks a Regulatory & Clinical Affairs Engineer to lead the FDA 510(k) clearance process for their monitoring technology. The ideal candidate will have a Bachelor's or Master's in Biomedical Engineering or related fields and strong communication skills. You will collaborate closely with teams to ensure compliance with regulatory requirements. The role offers a salary range of $60,000 - $80,000 depending on experience, with full-time work eligibility in the US required. #J-18808-Ljbffr InflammaSense
$60k - $80k
...and committed Biomedical or Bioengineering professional to join our dynamic... ...in bringing an innovative medical device to market, who will report... ...patients and clinicians. As a Regulatory & Clinical Affairs Engineer, you will lead the FDA 510(k) regulatory clearance...RegulatoryMedical deviceFull timeWork visa$79.1k - $131.9k
A leading healthcare company seeks a Quality Specialist to drive regulatory compliance within the Biomed Solutions business. This role involves... ...ensuring adherence to ISO and FDA standards. Candidates should have over 4 years of medical device service experience and a knack...RegulatoryMedical device- ...company is seeking a Director of Regulatory Affairs in California. The role involves leading regulatory strategy for Class... ...across departments, and overseeing FDA submissions. Candidates should... ...in regulatory affairs for medical devices, with a focus on Class III technologies...RegulatoryMedical device
$79.1k - $131.9k
MGM McKesson Medical-Surgical Inc. is seeking a Biomed Quality Specialist in California. This role involves driving regulatory and ISO compliance within the Biomed Solutions business and conducting... ...relevant experience in the medical device sector, be capable of mentoring teams...RegulatoryMedical device$140k - $185k
Kubelt is seeking a Senior Regulatory Specialist to drive global regulatory strategies for medical device and biologic products. In this role, you will lead regulatory submissions, manage regulatory... ...projects, and ensure compliance with FDA and international regulations....RegulatoryMedical device- A leading digital health company is seeking a Quality Control Manager to oversee quality... ...teams, ensuring compliance with regulatory standards, and leading continuous improvement... ...have over 8 years of experience in the medical device sector, a relevant bachelor's degree,...RegulatoryMedical device
$89.2k - $169.5k
A leading medical device company is looking for a Senior QA Auditor in California, responsible for planning, executing, and documenting audits... ...qualifications, making it an attractive opportunity in the regulatory landscape of the medical industry. #J-18808-Ljbffr Boston...RegulatoryMedical device- ...Quality Systems & Compliance Lead Virtual Job Description Posted... ..., and alignment with regulatory requirements. Role Responsibilities... ...regulatory requirements (FDA, EMA, ISO, etc.). Establish... ...within a regulated industry (medical devices, pharmaceuticals, or similar)...RegulatoryMedical deviceLocal area
- Regulatory Affairs Specialist - Medical Devices Position: Regulatory Affairs Specialist - Medical Devices Location: California... ...regulatory filings including 510(k)s, Technical Files, and other... ...submissions. Ensure compliance with FDA, EU MDR, ISO 13485, and other applicable...RegulatoryMedical deviceContract work
$183k - $228.8k
...Industrial Quality & Research, Medical Technology, Consumer... ...? The Senior Advisor,Regulatory and Clinical Affairs,... ...of a variety of FDA submissions including pre... ...pre-market notifications(510(k)s), pre-market approval... ...PMAs)andinvestigational device exemptions (IDEs). Inaddition...RegulatoryMedical deviceLocal areaRemote work- Lead Engineering, Regulatory, Quality and Clinical Affairs Recruiter, Medical Device & Diagnostics at BioTalent and Investigo, part of The IN Group... ...requirements set by the US FDA and European regulatory... ...submissions to the US FDA (e.g., 510(k), PMA) and EU Notified Bodies...RegulatoryMedical deviceFull time
- Lead Mechanic, Maintenance page is loaded## Lead Mechanic... ...*). Today, we have six FDA-approved therapies that... ...of cGMP and ISO regulatory knowledge* Strong ability... ...ability to use tablet devices* Strong working knowledge... ...in the pharmaceutical/medical devices industryJob...RegulatoryMedical deviceFor contractorsWork at officeLocal area
- ...rapid testing and point-of-care medical device solutions used in the... ...Job Type: Full time Job Title: Regulatory Affairs Manager Location: Onsite... ...regulatory requirements including FDA, ISO 13485, and other global... ...documents including 510(k), technical files, and other...RegulatoryMedical deviceFull timeFlexible hours
- ...rapid testing and point-of-care medical device solutions used in the... ...Full time Job Title: Associate Regulatory Affairs Manager Location: Onsite... ...projects, ensuring compliance with FDA, ISO 13485, and other global... ...submission process for 510(k), Technical Files, and other...RegulatoryMedical deviceFull timeWork at officeFlexible hours
$140k - $185k
...most serious unmet medical needs. We work to restore... ...options, creating devices aimed at restoring... .... The Senior Regulatory Specialist will serve... ...global markets. Lead, prepare, author, and... ...including IDEs, 510(k)s, PMAs, technical... ...authorities including FDA, Notified Bodies, and...RegulatoryMedical deviceFull timeLocal areaRemote workFlexible hours- A leading medical technology firm is seeking a Quality Control Manager to oversee quality control... ...teams, ensuring compliance with regulatory requirements, and driving continuous improvement... ..., a minimum of 8 years in a medical device manufacturing environment, and strong...RegulatoryMedical device
- A multinational biotech organization is seeking a Regulatory Affairs Manager to oversee regulatory documentation for medical device products. You will ensure compliance with FDA and ISO standards, provide regulatory support during product development, and collaborate with...RegulatoryMedical device
$90k - $100k
...this position About Mobia Medical Mobia Medical is a... ...is the first and only FDA‑approved implantable solution... ...or medical device environments, and a passion... ...appropriate legal and regulatory guidelines. Ability to... ...participate in the company 401(k) plan with company...RegulatoryMedical deviceLocal areaRemote work- Site Quality Leader (Medical Devices) The Opportunity A global, innovation-driven medical technology... ...in regulated environments and enjoys leading teams, influencing stakeholders, and... ...nonconformances, meet customer and regulatory requirements, and support business objectives...RegulatoryMedical device
- ...technology sales. You’ll engage leading clinicians, accelerate... ...firsts, including the first regulatory‑cleared connectomic neurosurgical... ...visualisation platform and the first FDA‑cleared neurological planning... ...KEY REQUIREMENTS 2+ years of medical device or hospital enterprise...RegulatoryMedical deviceRemote workWorldwideFlexible hours
- ...an immediate opportunity for a Regulatory Product Safety & Vigilance Specialist with a global medical device client. 1 Year Contract | Remote... ...Actions and regulatory audits (FDA, ISO, etc.) Qualifications 3-5... ...options, short-term disability, 401(k), weekly pay, and more. Johnson...RegulatoryMedical deviceWeekly payContract workTemporary workImmediate startRemote work
$117k - $175k
...for electro-mechanical medical devices. This role owns the hardware... ...mechanical solutions, lead tool design activities,... ...manufacturability and regulatory requirements* Lead... ...audits, and inspections (FDA, ISO 13485)**Let’s talk... ...commuter benefits, 401(k), Employee Stock Purchase...RegulatoryMedical deviceContract workTemporary workWork experience placementFlexible hours$89.2k
...485 compliance. The individual will lead audits end to end—developing audit plans... ...and managing external audits with regulatory bodies such as the FDA and notified bodies. The position... ...knowledge of quality systems within the medical device or pharmaceutical industry, strong...RegulatoryMedical deviceHourly payShift work- ...commercializing disruptive medical technologies. The ideal... ...Access & Contracting Lead contracting efforts... ...Finance, Reimbursement and Regulatory teams to ensure a... ...experience in medical device sales, national accounts... ...insurance premiums, a 401(k) plan with employer matching...RegulatoryMedical deviceContract work
- A leading biopharmaceutical company in California is seeking a Senior... ...engineering strategies for device combination products. The... ...overseeing HFE strategies, authoring regulatory deliverables, and... ...experience in human factors for medical devices, with strong communication...RegulatoryMedical device
$90k - $130k
...all aesthetic sales practices comply with regulatory, ethical, and organizational standards,... ...; prior experience in dermatological, medical devices, specialty pharmaceutical sales, or capital... ...benefits include health insurance, 401(k) plan with employer match, a generous...RegulatoryMedical deviceWork at officeShift workWeekend workAfternoon shift- ...today and address the medical challenges of tomorrow.... ...Description Associate Director, Regulatory Affairs US Advertising... ...setting strategy and leading cross-functional,... ...pharmaceutical/medical devices/biologics experience, pharmacy... ...insurance and 401(k) to eligible employees....RegulatoryMedical deviceTemporary workWork at office
- A global medical device company is seeking a Supplier Quality Engineer to join their Quality team. This role involves ensuring that purchased... ...materials and services meet all quality requirements and regulatory standards. The candidate should have at least 3 years of experience...RegulatoryMedical device
$172k - $344k
...Project Director/Manager in a medical device or software company,... ...Enablement, Commercial, Clinical, Regulatory, Privacy, Quality, and Manufacturing... ...and standards (e.g., FDA, ISO, QSR design controls) is... ...health) Paid time off 401(k) retirement savings with generous...RegulatoryMedical device$130.7k - $261.3k
...the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded... ...timely delivery and adherence to FDA-compliant design control procedures... ...processes and FDA 510K and PMA regulatory requirement· Good knowledge of...RegulatoryMedical device
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