Regulatory Affairs Director

Job Summary:iHealth Labs Inc. is seeking a highly skilled Regulatory Affairs Manager to join our team in Sunnyvale, California. As a key member of our regulatory team, you will be responsible for overseeing medical device development and market introduction. The successful candidate will have a minimum of 5 years of experience in medical device regulatory...

Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at iHealth Labs Inc.The ideal candidate will have a strong understanding of regulatory frameworks in the US, EU, and China, and be able to communicate effectively with regulators to obtain pre-market approval/clearance.Key ResponsibilitiesDevelop and implement...

Lead Regulatory Affairs efforts for Orca Bio, a late-stage biotechnology company developing cell therapies.The ideal candidate will have 12+ years of regulatory experience, including 8+ years in leadership within the biotech/pharmaceutical industry or as a seasoned regulator.We offer a competitive salary range of $180,000 - $250,000 based on prior...

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+...

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...

About the RoleiHealth Labs Inc. is seeking a seasoned Regulatory Compliance Specialist to join our team in Sunnyvale, California.In this critical role, you will be responsible for developing and implementing regulatory strategies for medical devices, ensuring compliance with relevant regulations and industry standards.The ideal candidate will have a strong...

Join Orca Bio, a late-stage biotechnology company redefining the transplant process with next-generation cell therapies. As our Head of Regulatory Affairs, you will lead our regulatory strategy and operations.Role OverviewThis role is ideal for a seasoned regulator or leader with 12+ years of experience in regulatory affairs within the biotech/pharmaceutical...

Key ResponsibilitiesAs a Regulatory Affairs Manager at iHealth Labs Inc in Sunnyvale, California, you will be responsible for:Managing regulatory pre- and post-market activities, including preparation and submission of regulatory applications to the US FDA and international authorities.Ensuring compliance with relevant regulations, including ISO 13485, FDA,...

Unlock Career Opportunities at Orca BioWe are driven by a passion for science and compassion for patients. Our goal is to ensure that our treatments are accessible to all who need them.As a leading biotech company, we value excellence in our work and the chance to unlock a better quality of life for our patients. We take tremendous responsibility for...

Regulatory Affairs OpportunityWe are looking for a highly motivated Senior Associate to join our regulatory affairs team. The ideal candidate will have a strong background in regulatory affairs and experience working with global regulatory agencies.Key Responsibilities:Support processes by which regulatory submissions are reviewed, finalized, and...

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...

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...

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...

The estimated salary for this role is $182,500 per year, based on the job requirements and industry standards. This compensation package includes benefits, bonus, stock options, and other applicable variable compensation.Job DescriptionMain Responsibilities:Provide regulatory guidance to project teams and key sub-teams at study levelAssess, develop, and...

Job Title: Compliance and Regulations ManagerCompany 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...

About the PositionWe are seeking an experienced and skilled Geriatrics Medical Director to lead our team at the Department of Veterans Affairs Community Living Center in Menlo Park, CA.Key Responsibilities:Develop and implement clinical policies and procedures to ensure high-quality patient care.Oversee the scheduling of advance practice providers and...

Job SummaryWe are seeking a skilled and compassionate Nurse Medical Unit Director to lead our healthcare team at Kaiser Permanente. As a key member of our organization, you will be responsible for providing professional nursing care, utilizing the nursing process in accordance with established standards of care, policies, and procedures.You will demonstrate...

Job OverviewWe are seeking an experienced Compliance Director to lead our regulatory efforts at Graton Resort & Casino. The successful candidate will have a strong background in compliance, audit management, and team leadership.Estimated Salary: $120,000 - $180,000 per yearKey Responsibilities:Raise the bar for hospitality at Graton Resort & Casino by...

Director of Statistical StrategySummit Therapeutics Sub, Inc. is seeking a director of statistical strategy to provide strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success.Essential SkillsIn-depth knowledge of CDISC standards.Technical expertise and knowledge of experimental design and analyses...

Company OverviewBillionToOne is a pioneering molecular diagnostics company that has revolutionized the industry with its cutting-edge technology. The company's innovative QCT molecular counting technology has significantly enhanced the resolution of disease detection using cell-free DNA by over a thousandfold.This groundbreaking technology is integral to...