Compliance and Regulations Manager

3 weeks ago


Baldwin Park, California, United States Ihealth Labs Inc Full time

Job Title: Compliance and Regulations Manager

Company Overview:

iHealth Labs Inc is a pioneer in the digital health industry, dedicated to transforming healthcare through innovative medical devices and technologies.

Job Description:

This role requires a seasoned Compliance and Regulations Manager to oversee the regulatory compliance of our medical devices and ensure that all submissions to the US FDA and international regulatory authorities are accurate and timely.

Key Responsibilities:

  • Development and implementation of regulatory strategies for new products and technologies.
  • Cross-functional collaboration with Quality, Engineering, Product Management, Marketing, and Sales teams.
  • Review and approval of change order packets and provide regulatory impact assessment for changes to medical devices.

Qualifications:

  • Master's degree in Life Sciences, Engineering, Math, or a medical field with a focus on technical writing, scientific methodologies, and problem-solving.
  • A minimum of 5 years of experience in medical device Regulatory Affairs, showcasing a comprehensive understanding of regulatory frameworks in the US, EU, and China.
  • Demonstrated ability to communicate and negotiate with regulators for the least burdensome approaches to pre-market approval/clearance.

Benefits:

$80,000 - $140,000 per year, plus a comprehensive benefits package including medical, dental, vision, life insurance, and 401K.

],

  • Baldwin Park, California, United States Ihealth Labs Inc Full time

    About the RoleiHealth Labs Inc is seeking a Medical Device Compliance Manager to join our regulatory team.The successful candidate will have a strong background in medical device regulations and a proven track record of ensuring compliance with regulatory requirements.Key ResponsibilitiesDevelop and implement regulatory strategies to ensure compliance with...


  • Baldwin Park, California, United States Ihealth Labs Inc Full time

    Regulatory Affairs ManagerJoin our team as a Regulatory Affairs Manager at iHealth Labs Inc., where you will be responsible for overseeing the regulatory affairs function across the organization.This role requires a strong understanding of regulatory frameworks in the US, EU, and China, as well as excellent communication and negotiation skills. You will lead...


  • Baldwin Park, California, United States Professional Search Group - Orange County Full time

    ResponsibilitiesServe as a primary point of contact for third-party contractors and consultants on projects involving regulated substances.Facilitate communication with governmental agencies and city departments regarding environmental issues related to URP and BD sites.Ensure timely coding and submission of invoices and check requests to Accounts...


  • Baldwin Park, California, United States Professional Search Group - Orange County Full time

    Job Title: Regulatory Compliance CoordinatorProfessional Search Group - Orange County is seeking a highly skilled Regulatory Compliance Coordinator to join their team. The successful candidate will support the Environmental and Regulatory Department for our client by ensuring compliance with environmental regulations.Job Summary:The Regulatory Compliance...


  • Baldwin Park, California, United States Ihealth Labs Inc Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at iHealth Labs Inc. in Sunnyvale, California.This role will be responsible for overseeing the development and implementation of regulatory strategies for medical devices, ensuring compliance with ISO 13485, FDA, and MDR/IVDR regulations.The ideal candidate will have a...


  • Baldwin Park, California, United States Ihealth Labs Inc Full time

    About the RoleWe are looking for a talented Regulatory Affairs Manager to lead our regulatory efforts at iHealth Labs Inc in Sunnyvale, California. This position will involve managing regulatory pre- and post-market activities, preparing and submitting regulatory applications to the US FDA and international authorities, and ensuring compliance with relevant...


  • Baldwin Park, California, United States Ihealth Labs Inc Full time

    About the Role:We are looking for an experienced Regulatory Affairs Manager to join our team at iHealth Labs Inc. in Sunnyvale, California. As a key member of our regulatory team, you will be responsible for ensuring that our medical devices comply with regulatory requirements in the US, EU, and China. The successful candidate will have a minimum of 5 years...


  • Baldwin Park, California, United States Professional Search Group - Orange County Full time

    Job Title: Environmental Program ManagerWe are seeking an experienced Environmental Program Manager to join our team at Professional Search Group - Orange County. The successful candidate will support the Environmental and Regulatory Department for our client by managing environmental programs and ensuring compliance with environmental regulations.Job...


  • Baldwin Park, California, United States Sully-Miller Contracting Co. Full time

    Job DescriptionThe Environmental Program Manager will oversee various environmental programs and initiatives at Sully-Miller Contracting Co., ensuring compliance with regulations and standards while promoting sustainable practices.Main ResponsibilitiesDevelop and implement strategies to improve environmental performance and reduce the company's ecological...


  • Baldwin Park, California, United States Paramount Logistics Inc Full time

    About the PositionWe are seeking a highly skilled Accounting Supervisor to join our team at Paramount Logistics Inc. The successful candidate will be responsible for managing a team of accountants and clerks, ensuring accurate and timely financial reporting, and maintaining internal controls to safeguard our financial data and assets.The ideal candidate will...

  • Global RA Manager

    3 weeks ago


    Baldwin Park, California, United States Ihealth Labs Inc Full time

    Job DescriptioniHealth Labs Inc. is a leading provider of cloud-connected medical devices, personal health care devices, and home-based tests, revolutionizing the healthcare industry through quality health management and affordability.We are seeking a dedicated Medical Device Regulatory Lead to join our team in Sunnyvale, California, focusing on developing...


  • Menlo Park, California, United States Exponent Full time

    About the OpportunityWe are seeking an experienced Environmental Scientist to join our team at Exponent. As a key member of our Environmental & Earth Sciences Practice, you will be responsible for providing support for chemical regulatory compliance projects and high-level scientific support for environmental forensics and chemistry...

  • Compliance Manager

    19 minutes ago


    Menlo Park, California, United States Aerotek Full time

    Job SummaryThis Healthcare Regulatory Compliance Lead position requires a strong understanding of regulatory requirements and certification agencies, with a focus on ensuring compliance with rules affecting safety, security, hazardous waste, medical equipment, fire/life safety, and utilities.ResponsibilitiesEnsure daily regulatory compliance through regular...


  • Baldwin Park, California, United States Ready Pac Produce, Inc Full time

    Join Our TeamBonduelle Americas is a dynamic and growing company that values its employees' well-being and safety. We are seeking an experienced EHS Specialist to join our team in Irwindale, CA.Key ResponsibilitiesLead safety inspections and audit programs to ensure compliance with environmental, health, and safety regulations.Develop and review procedures...


  • Baldwin Park, California, United States Avnan Full time

    We are seeking an experienced U.S. Accounting Manager to lead the financial operations of two U.S.-based entities, each supported by a dedicated finance team of one.This role offers an exciting opportunity to manage financial operations across borders, requiring expertise in both U.S. and Canadian accounting principles.Responsibilities:Provide accurate,...

  • HR Generalist

    1 day ago


    Baldwin Park, California, United States Michael Page Full time

    This role supports the client's manufacturing and production employee population, handling onboarding to offboarding responsibilities.Key DetailsThe company is a growing Manufacturing organization undergoing expansion.DescriptionTalent Acquisition and OnboardingStrategic Recruitment: Manage end-to-end recruitment processes, including job postings, candidate...


  • Baldwin Park, California, United States Ready Pac Produce, Inc Full time

    About UsReady Pac Produce, Inc is a certified B Corp inviting people to embrace a flexitarian lifestyle with an expanding portfolio of plant-rich products available in and beyond the produce aisle. We operate four facilities and employ nearly 3,000 Associates in the US.Bonduelle Americas, our parent company, is a wholly-owned subsidiary of Groupe Bonduelle...

  • Compliance Specialist

    4 weeks ago


    Monterey Park, California, United States Incompli Full time

    About Incompli:We simplify environmental compliance with technology and efficiency at Incompli. Our team of stormwater professionals has years of experience with complex environmental regulations.Job Overview:This role ensures sites comply with state and local permits by conducting assessments, performing field sampling, and providing analytical reporting in...


  • Baldwin Park, California, United States Paramount Logistics Inc Full time

    Job OverviewParamount Logistics Inc is seeking a highly skilled Senior Accountant to lead our accounting department. This is an exceptional opportunity for an experienced professional to take charge of the day-to-day operations, ensuring accurate and timely financial reporting.Key Responsibilities1. **Team Leadership:** Supervise a team of accountants and...


  • Baldwin Park, California, United States Professional Search Group - Orange County Full time

    We are recruiting a Regulatory Affairs Professional to support our client's Environmental and Regulatory Department. As a key member of the team, you will be responsible for ensuring compliance with local, state (CA), and federal environmental regulations.The ideal candidate will have a Bachelor's Degree in Environmental Science or a related field and 2+...