Regulatory Specialist - Digital Health & SaMD
Intellectt Inc
Intellectt Inc is seeking a Regulatory Specialist to support sustaining releases for digital health devices and software/hardware with sensors. You will independently manage regulatory assessments and documentation for product changes, including Letters to File, in a fast-paced cross-functional environment. The role requires U.S. Regulatory Affairs experience, ability to navigate change assessments, and collaboration with software, hardware, and clinical teams to ensure compliance for market in #J-18808-Ljbffr Intellectt Inc
$90k - $180k
...AlamedaJob Type: Full timeCategory: Regulatory AffairsIndustry:... ...science to improve people’s health. We’re always looking towards... ...Biowearable technology will digitize, decentralize and democratize... ...the Senior Regulatory Affairs Specialist will support product development...Suggested$100k - $200k
...free medical coverage in our Health Investment Plan (HIP) PPO medical... ...Opportunity The Principal RA Specialist will work on-site out of our... ...for leading global regulatory submissions, which include but... ...include medical hardware and digital health technology solutions to...SuggestedShift work$100k - $200k
...of.Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next... ...technology. The Opportunity This Principal International Regulatory Operations Specialist will work on-site at our Alameda, CA location in the Diabetes...SuggestedWorldwideShift work$148.7k - $297.3k
...science to improve people’s health. We’re always looking towards... ...Opportunity This Associate Director Regulatory Affairs will work on-site out... ...diabetes management and digital health technology solutions.... ...Software as a Medical Device (SaMD)Experience with FDA QSR and...SuggestedWorldwideShift work$81.5k - $141.3k
Abbott is looking for a Medical Events Group Specialist I in Alameda, CA, to manage the... ...device incidents, ensuring compliance with regulatory authorities. The role requires a Bachelor... ...for its diverse workplace and offers many health benefits, with a salary range of $81,500...Suggested- ...Alameda, CA is seeking a Medical Events Group Specialist (Operations) to ensure timely review,... ...of medical device reports to FDA, Health Canada, EU/EFTA and other global authorities... ..., and adapt processes to evolving regulatory requirements while delivering high‑quality...
- Abbott is hiring a Senior Specialist for the Medical Events Group based in Alameda, CA. This role focuses on managing medical device reports and ensuring compliance with regulatory authority standards. The ideal candidate will have a Bachelor’s Degree in a related field...
$117.44k - $176.16k
We are so glad you are interested in joining Sutter Health!Organization:SHSO-Sutter Health System Office-ValleyPosition Overview:This position is responsible for imaging project implementation and development.*Experience with PACS, viewer, and cloud image sharing is highly...Full timeWork at officeRemote workShift work- ...Job Description Job Description Asian Health Services, founded in 1974, provides medical, dental, and behavioral health services... ...(CAO) and Compliance Department Manager to comply with legal, regulatory, and grant standards such as HRSA Operational Site Visit, Federal...Work experience placementFlexible hours
$100k - $200k
...dream of.Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar... ...welcome all to apply.What You’ll Work OnDevelop and execute HCP digital content strategies that support omnichannel marketing initiatives...Worldwide- Regulatory Specialist with experience supporting sustaining activities, digital health/mobile applications, change assessments, and U.S. regulatory affairs . The candidate should... ...experience Software as a Medical Device ( SaMD ) experience Experience with multifunction...
- ...coordinating implementation of compliance efforts, and assisting with regulatory compliance through monitoring regulatory changes. This... ...adherence.QualificationsMinimum Qualifications:Bachelors degree in Health Care Administration, Clinical, Law, Public Health, Business or...Work experience placement
- Tiburcio Vasquez Health Center, Inc. (Hayward, CA) is seeking an Early Childhood Quality Assurance Coordinator. The role supports the FSS team with QA, workflow coordination, and data quality monitoring, maintaining a reduced caseload of about five families. This full-...Full time
- We are seeking an experienced Senior Regulatory Specialist with strong expertise in Medical Device Regulatory Affairs to support regulatory activities across the product lifecycle. The ideal candidate will have at least 7 years of experience in medical device regulatory...
- Abbott in Alameda, CA, seeks a Senior Specialist in the Medical Events Group to manage timely review, documentation and filing... ...Device Reports to the FDA, Medical Problem Reports to Health Canada, and related regulatory submissions for the division's products. You will...
- Job Title: Regulatory Specialist Sr Location: Alameda , CA Pay Range: $55/hr to $58/hr on W2 What's the Job? Ensure timely approval of new medical... ...Medical and Prescription Drug Plans Dental Plan Vision Plan Health Savings Account Health Flexible Spending Account Dependent...Weekly payTemporary workFlexible hours
$54 per hour
...Job Description Job Description Job Title: Regulatory Specialist Sr Job Description The Regulatory Specialist Sr plays a key role in ensuring... ...employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee...Contract workTemporary workWork at office- ...Benefits The Department of Motor Vehicles and the State of California offer many benefits to its employees. These include health, vision, and dental benefits; retirement plans (CalPERS); savings plans (401K and 457b); leave benefits; insurance (such as group legal...Full timeWork at officeRelocation
- Penumbra, Inc. in Alameda, CA is seeking a Product Stewardship Specialist I to develop, implement, and support quality system elements... ...decisions, and support audits and documentation. The role emphasizes regulatory knowledge, meticulous data handling, cross‑functional...
- ...network of established financial protection specialists. This 1099 entrepreneurial partnership... ...on all policy renewals. Advanced Digital Ecosystem: Leverage full access to enterprise... ...: Possess a valid, active Life and Health (or Life-only) lines authority in your home...Contract workWork at officeImmediate startRemote work
$24 - $27.6 per hour
...knowledge to educate and empower clients Maintain licensure and uphold hygiene standards Keep licenses active and always uphold health and safety protocols Foster inclusiveness and teamwork Help promote a culture of openness where everyone feels empowered...Hourly payPermanent employmentFull timePart timeFlexible hoursShift workNight shiftWeekend work$150k - $200k
...will support critical compliance initiatives across a client’s generation assets. This role will focus on ensuring adherence to regulatory requirements, internal cybersecurity standards, and industry best practices. The ideal candidate will have a proven track record...Full timeWork at officeRemote work- ...policies. The Government Programs Compliance Specialist, Senior will report to the Senior... ...partnering with business teams to promote regulatory compliance and corrective action. Your... ...Services (CMS) and the Department of Health Care Services (DHCS). Document final...Full timePart timeWork at officeLocal areaWork from homeHome office2 days per week
$55 - $60 per hour
...or supports maintaining a complete and accurate inventory of regulatory requirements, including identifying requirement owners, and mapping... ...Payroll with physical offices in US, Canada, and India. GTT Digital headquartered in Toronto specializes in providing high-tech...Contract workWork at officeLocal areaWork visa- Terrestris LLC is seeking a Laboratory Records & Administrative Specialist in Alameda, California, to support the FDA's Office of Regulatory Testing. This role is crucial for ensuring the integrity of laboratory records through document management, scanning, and administrative...Full timeWork at office
- Position Summary The Regulatory Analyst supports policy scanning, requirements management, and strategic planning activities within the Electric Compliance organization. This role conducts research and analysis of regulatory developments, maintains compliance documentation...Work experience placementWork at officeLocal areaRemote work
- A leading IT staffing company in Emeryville is looking for a qualified candidate to support the maintenance of their Global Regulatory Affairs filing system and RTS database. The role emphasizes effective organization, knowledge of compliance, and project execution skills...Work at office
- ...will be responsible for supporting the maintenance of the Global Regulatory Affairs filing system and the Registration Tracking System (RTS... ...required certificates and tracking of submission under Health Authority review. Continued maintenance of these systems helps...Work at officeImmediate start
- ManpowerGroup Global, Inc. seeks a Regulatory Affairs Associate in Alameda, CA, to support the Regulatory Affairs team by ensuring compliance and collaborating on regulatory submissions. The ideal candidate holds a Bachelor's degree and has at least 2 years in regulated...
$40 - $45 per hour
Job Title: Regulatory Affairs Associate Location: Alameda, CA Work Arrangement: 100% Onsite Duration: 12 Months Pay Range: $40 - $45... ...support. Support regulatory submissions, including 510(k), PMA, Health Canada, and Latin America submissions. Assist with NPI and...Hourly pay
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