Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Regulatory Submissions Lead — Medical Devices (FDA/Canada)

Waymo

Waymo in Tempe, AZ is seeking an experienced Regulatory Affairs professional to manage FDA 510(k) submissions and Canadian applications for medical devices. You will review test protocols, prepare regulatory correspondence, and ensure compliance across engineering, manufacturing, and quality teams. The role requires a life science degree and 8+ years in medical device regulation, with expertise in 21 CFR 820, MDSAP, and ISO standards. #J-18808-Ljbffr Waymo

Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Regulatory Submissions Lead — Medical Devices (FDA/Canada) in Tempe, AZ vacancy
  •  ...Sr. R&D Engineer Medical Devices Company Job Title – Sr...  ...plans and ability to lead cross functional teams...  ...position is to lead EU-MDR submission of products, including...  ..., Operations, and Regulatory Affairs. Roles & Responsibilities...  ...or other regulated FDA/QSR and ISO... 
    Regulatory
    Medical device
    Contract work
    Temporary work
    Work at office
    Local area
    Day shift
    3 days per week

    MILLENNIUMSOFT

    Tempe, AZ
    2 days ago
  •  ...st Shift Client: Medical Device Company Employment...  ...to support EU-MDR submission of products, including...  ...as well as applicable regulatory requirements. 4. Design...  ...guidelines. • Support/lead design and process...  ...intermediate knowledge of FDA/ISO requirements... 
    Regulatory
    Medical device
    Contract work
    H1b
    Day shift

    MILLENNIUMSOFT

    Tempe, AZ
    3 days ago
  •  ...will play a pivotal role in leading our product development...  ...compliance with all relevant regulatory requirements, including FDA, CE, and other applicable...  ..., the clinical team, and medical science to solicit input and...  ...in aortic medical device development. Minimum 10 years... 
    Regulatory
    Medical device
    Contract work

    Klein Hersh

    Tempe, AZ
    5 days ago
  • MillenniumSoft Inc is seeking a Sr. Regulatory Affairs Specialist in Tempe, AZ for a 12+ month contract. The role involves managing product remediation and regulatory submissions to market medical devices in the EU. Qualified candidates should have a Bachelor's degree... 
    Regulatory
    Medical device
    Contract work
    Local area

    MillenniumSoft Inc

    Tempe, AZ
    2 days ago
  •  ...Position Regulatory Affairs Specialist [Local & Remote eligible] Location Tempe, AZ Duration...  ...Hours 40 hours/week, 1st Shift Client Medical Device Company Job Category Regulatory...  ...remediation initiatives. Prepare regulatory submissions required to legally market medical... 
    Regulatory
    Medical device
    Contract work
    H1b
    Local area
    Remote work
    Flexible hours
    Day shift

    MILLENNIUMSOFT

    Tempe, AZ
    3 days ago
  •  ...Job Information Position: Sr. Regulatory Affairs Specialist Location: Tempe, AZ Duration...  .../week: 40.00 Shift: 1st Shift Client: Medical Device Company Job Category: Regulatory...  ...projects, and the preparation of regulatory submissions required to legally market medical... 
    Regulatory
    Medical device
    Contract work
    Part time
    H1b
    Local area
    Remote work
    Flexible hours
    Shift work
    Day shift

    MILLENNIUMSOFT

    Tempe, AZ
    3 days ago
  • $159.8k - $255.7k

     ...including marketing, sales, regulatory affairs, and R&D, to provide...  ...product areas include biopsy devices and markers, vascular access,...  ...Attend assigned scientific and medical congresses to capture information...  ...laws (OIG), regulations (FDA), and ethical standards (ACCME... 
    Regulatory
    Medical device
    Local area
    Worldwide

    JobRx, Inc.

    Tempe, AZ
    5 days ago
  •  ...: Shift 8 am to 5:00 pm Client: Medical Device Company Employment Type: Contract...  ...supervisory and/or fiscal): EU-MDR submissions: leads Quality activities surrounding EU-MDR...  ...business needs as well as applicable regulatory requirements. Design to Manufacturing... 
    Regulatory
    Medical device
    Contract work
    H1b
    Work at office
    Shift work
    Day shift

    MILLENNIUMSOFT

    Tempe, AZ
    2 days ago
  •  ...0 1st Shift Client: Medical Device Company Job Category: Engineering...  ...methodologies • Lead cross-functional teams to develop...  ...company procedures on regulatory requirements • Provide support...  ...in writing technical submissions • Provide positive example... 
    Regulatory
    Medical device
    Contract work
    Work experience placement
    H1b
    Day shift

    MILLENNIUMSOFT

    Tempe, AZ
    2 days ago
  • ROMTech is a medical technology company that has created and patented a revolutionary medical device and telemedical platform which delivers in...  ...to operational efficiency, regulatory compliance, and patient...  ...neededEnsure compliance with OSHA, FDA, and DOT requirements (... 
    Regulatory
    Medical device
    Shift work

    ROMTech

    Tempe, AZ
    4 days ago
  •  ...Hours/week: 40.00 1st Shift Client: Medical Device Company Employment Type: Contract...  ...the support of Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant...  ...Experience in medical device or other regulared FDA/QRS and ISO environment • Ability to... 
    Regulatory
    Medical device
    Contract work
    Work experience placement
    H1b
    Day shift

    MILLENNIUMSOFT

    Tempe, AZ
    2 days ago
  •  ...Hours/week: 40.00 1st Shift Client: Medical Device Company Job Category: Engineering...  ...the support of Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant...  ...preferably in medical device or other regulated FDA/QSR and ISO environment. Ability to work... 
    Regulatory
    Medical device
    Contract work
    H1b
    Local area
    Day shift

    MILLENNIUMSOFT

    Tempe, AZ
    3 days ago
  •  ...ROMTech is a medical technology company that has created and patented a revolutionary medical device and telemedical platform which delivers...  ...to operational efficiency, regulatory compliance, and patient satisfaction...  ...compliance with OSHA, FDA, and DOT requirements (... 
    Regulatory
    Medical device

    ROM Technologies, Inc.

    Tempe, AZ
    2 days ago
  •  ...accuracy and distribution, ensuring optimal operational efficiency and compliance with regulatory standards. Responsibilities include overseeing the receiving and shipping of medical devices, maintaining accurate inventory records, and supporting both patient deliveries and... 
    Regulatory
    Medical device

    ROM Technologies, Inc.

    Tempe, AZ
    3 days ago
  •  ...the frontiers of medicine and leading a revolution in healthcare—...  ..., Laboratory Operations, Regulatory Affairs, and Commercial teams...  ...bioinformatics solutions in diagnostics, medical devices, pharmaceuticals, or high-...  ...of GxP, CLIA, CAP, and FDA quality systems.* Proven... 
    Regulatory
    Medical device
    Casual work
    Work at office

    Caris Life Sciences, Ltd.

    Tempe, AZ
    3 days ago
  • A leading clinical-stage biotech company is seeking a Vice President of Product Development...  ...will have a strong background in medical device development, project management expertise...  ...role involves strategic leadership, regulatory compliance, and collaboration across functions... 
    Regulatory
    Medical device

    Klein Hersh International

    Tempe, AZ
    5 days ago
  •  ...hours per week Shift 1st Shift Client Medical Device Company Experience Level Entry Level Employment...  ...(s) in compliance with Company and Regulatory policies. 10% Ensure that all...  ...10% Handle all complaints according to FDA/ISO/cMDR and other regulations governing... 
    Regulatory
    Medical device
    Contract work
    Work experience placement
    Work at office
    Remote work
    Work from home
    Flexible hours
    Shift work
    Day shift

    MillenniumSoft Inc

    Tempe, AZ
    3 days ago
  •  ...Summary Position Summary The Lead Clinical Research Coordinator...  ...standards. Prepare and submit IRB submissions, amendments, continuing...  ...sponsors, CROs, monitors, and regulatory bodies. Maintain and organize...  ...documentation in compliance with FDA and GCP requirements. Monitor... 
    Regulatory
    Work at office
    Afternoon shift

    Elite Clinical Network

    Chandler, AZ
    4 days ago
  •  ...Company Description As a leading healthcare education organization...  ...teaching and training of emergency medical technician (EMT) students....  ...adheres to educational and regulatory standards Teach essential EMT...  ..., such as manikins, medical devices, and PPE, are used safely and... 
    Regulatory
    Medical device
    Part time
    Local area

    Unitek Learning

    Tempe, AZ
    4 days ago
  •  ...clinical projects and monitor staff workload. Ensure timely submission of timesheets and expense reports by staff. Develop, mentor,...  ...of Good Clinical Practice, 21 CRF Part 11, and other relevant regulatory requirements; Dedication to quality and reliability; Commitment... 
    Regulatory
    For contractors
    Flexible hours

    Jobtailor

    Tempe, AZ
    3 days ago
  •  ...relationships with manufacturing companies, laboratory facilities, medical device organizations, aerospace firms, and other calibration-...  ...awarded work. Maintain compliance with all company, safety, and regulatory requirements. Skills and Qualifications Minimum 3+ years of... 
    Regulatory
    Medical device
    Price work
    Work at office
    Local area

    Fountain-Fort Carson School District 8

    Tempe, AZ
    2 days ago
  •  ...transactions while ensuring compliance with industry regulations. You will lead a team, offer expert guidance, and establish supervisory practices across the organization. The ideal candidate has a solid regulatory background, excellent communication skills, and is committed to... 
    Regulatory

    Edward Jones

    Tempe, AZ
    4 days ago
  •  ...month contract Total Hours/Week 40 hours Shift 1st Shift Client Medical Device Company Job Category Admin/Clerical Level Of Experience Entry...  ..., Excel, Microsoft Teams, and OneDrive May participate in FDA, Corporate, and internal audits Performs data analysis and system... 
    Medical device
    Contract work
    Local area
    Shift work
    Day shift

    MILLENNIUMSOFT

    Tempe, AZ
    1 day ago
  • Rockford Fosgate is looking for a Global Compliance Specialist to manage regulatory compliance activities for audio electronics worldwide. You will coordinate certification efforts and maintain supplier certificates. The ideal candidate has 3-5 years of regulatory compliance... 
    Regulatory
    Work at office
    Worldwide
    Flexible hours

    Rockford Fosgate

    Tempe, AZ
    1 day ago
  •  ...Duration: 12 Months Total Hours/week: 40.00 1st Shift Client: Medical Devices Company Job Category: Professional Level of Experience:...  ...improvement of lab processes Understand and follow procedures and regulatory requirements Required Qualifications Good written and verbal... 
    Regulatory
    Medical device
    Contract work
    Day shift

    MILLENNIUMSOFT

    Tempe, AZ
    2 days ago
  •  ...Total Hours/week: 40.00 Client: Medical Device Company Employment Type: Contract on...  ...the support of Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with...  ...Experience in medical device or other regulared FDA/QRS and ISO environment • Ability to... 
    Regulatory
    Medical device
    Contract work
    Work experience placement
    Work at office

    MILLENNIUMSOFT

    Tempe, AZ
    3 days ago
  •  ...employees Comprehensive insurance plans for medical, dental and vision coverage for full‑...  ...Electronic medical records and mobile devices for all clinicians Incentivized bonus plan...  ...in patient’s record per internal regulatory and professional standards. Monitor, observe... 
    Regulatory
    Medical device
    Full time
    Work experience placement
    Relief
    Flexible hours

    Enhabit Home Health & Hospice

    Tempe, AZ
    3 days ago
  •  ...Human Resources, Investor Relations, and other cross‐functional teams to support regulatory compliance, governance operations, and Board and executive activities for a global medical device technology company. You will be a trusted operational partner known for sound... 
    Regulatory
    Medical device
    Hourly pay
    Full time
    Temporary work
    Internship
    Work at office
    Local area
    Flexible hours

    Align Technology

    Tempe, AZ
    1 day ago
  •  ...2 Months Total Hours / Week 40.00 Shift 1st Shift Client Medical Devices Company Job Category Quality Level of Experience Entry - Level...  ...and test methods. Understand and follow procedures and regulatory requirements. Use calibrated laboratory equipment and tools... 
    Regulatory
    Medical device
    Contract work
    Shift work
    Day shift

    MillenniumSoft Inc

    Tempe, AZ
    2 days ago
  •  ...in Tempe, AZ seeks a Third Party Management Office governance lead responsible for establishing TPMO standards and procedures, governing...  ...offers a challenging governance environment with exposure to regulatory alignment, risk management, and #J-18808-Ljbffr Northern Trust... 
    Regulatory
    Work at office

    Northern Trust Corp

    Tempe, AZ
    3 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Regulatory Submissions Lead — Medical Devices (FDA/Canada). Be the first to apply!