Regulatory Compliance Lead

We are seeking a skilled Global Regulatory Compliance Manager to join our team at AbbVie. In this role, you will be responsible for ensuring the compliance of our medical devices with global regulatory requirements. This includes developing US regulatory filing strategies, providing regulatory strategy and guidance to global product development teams, and...

AbbVie is seeking a highly motivated Body Contouring Regulatory Lead to join our team. In this role, you will be responsible for leading the development of regulatory strategies for our body contouring products. This includes planning and implementing regulatory activities that support lifecycle management, reviewing labeling and packaging components to...

Key ResponsibilitiesThe successful candidate for this Global Regulatory Compliance Manager role will have extensive experience in regulatory affairs, particularly in medical device manufacturing companies, and be well-versed in FDA QSR, ISO 13485, and other relevant regulations.

Key ResponsibilitiesHost client and regulatory inspections, preparing responses to findings.Support organization regulatory professionals across sites.Assure GLP protocol requirements are met through auditing phase-specific raw data and reports.Establish and maintain a state of inspection readiness, including site-specific folders.Establish company...

About the RoleWe are looking for a highly skilled Global Regulatory Lead to join our team at AbbVie. As a key member of our regulatory affairs group, you will be responsible for developing and implementing regulatory strategies to support lifecycle management.The ideal candidate will have extensive knowledge of regulatory requirements and regulations, with...

About the RoleWe are seeking a highly experienced Regulatory Affairs Specialist to join our team at Abbott Laboratories in Pleasanton, CA. As a key member of our Heart Failure Division, you will play a critical role in ensuring the regulatory compliance of our medical devices.Key ResponsibilitiesDevelop and implement global regulatory strategies for new and...

About the RoleDynamic Office & Accounting Solutions seeks a seasoned Safety & Compliance Specialist to drive regulatory compliance and maintain a safe work environment across our diverse operations.Job OverviewThis is a full-time, on-site position offering a sign-on bonus and comprehensive benefits package.Main Responsibilities:Lead site inspections, safety...

Job OverviewA leading global healthcare company, Abbott Laboratories, seeks an experienced Regulatory Affairs Specialist to join its Heart Failure Division in Pleasanton, CA. As a key member of the regulatory department, this individual will ensure efficient and compliant business processes and environment.Key ResponsibilitiesThis role involves providing...

Job DescriptionCandidate is expected to establish and administer quality systems supporting compliant nonclinical laboratory study GLP and or phases thereof and testing activities producing primary or secondary endpoints of clinical studies GCLP. The individual should assure that facilities, equipment, personnel, methods, practices, records, and controls are...

At AbbVie, we are dedicated to discovering and delivering innovative medicines and solutions that solve serious health issues. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements. This includes planning and preparing complex regulatory documents for US and ROW...

About Abbott LaboratoriesAs a global leader in healthcare, Abbott Laboratories helps people live more fully at all stages of life. Our diverse portfolio includes life-changing technologies spanning diagnostics, medical devices, nutritionals, and branded generic medicines. We serve people in over 160 countries, with 114,000 colleagues worldwide.Career...

About the PositionWe are seeking an accomplished Senior Engineering Manager to lead our Disposable Instruments Development Team. As a key member of our R&D department, you will be responsible for driving the design and development of advanced medical devices. The ideal candidate will have expertise in mechanism and control systems design, with experience in...

Calyxo, a pioneering medical device company in Pleasanton, California, is seeking an exceptional engineering leader to spearhead the development of cutting-edge vision and sensor systems for endoscopic devices and capital equipment. The ideal candidate will oversee a multidisciplinary team responsible for designing and developing hardware and firmware...

Responsibilities:Coordinate project activities between clients, external teams, and internal stakeholders.Develop and implement project schedules to ensure timely completion.Manage project documentation, including submittals, tracking logs, and change orders.Communicate effectively with clients and utility business partners.Monitor project progress and...

Job DescriptionAs a Utility Project Lead, you will oversee the coordination between the client, external project team, public utility team, drafting team, and other project stakeholders. You will be responsible for setting priorities, preparing project schedules, and working on multiple projects in a team-based environment with a focus on delivery and...

Job OverviewCrystal Pharmatech seeks a highly experienced Director of Quality Assurance to lead the development, implementation, and maintenance of quality systems ensuring compliance with regulatory requirements.The ideal candidate will have a strong background in regulatory affairs, with expertise in GLP and GCLP regulations. They will be responsible for...

OverviewLifelancer is a leading talent-hiring platform in Life Sciences, Pharma, and IT.CompensationThe estimated annual salary for this position is between $85,000 - $210,000. Please note that actual salaries may vary within the range above or below, depending on experience and location.Job DescriptionWe are seeking an experienced Engagement Manager to join...

At Calyxo, we're committed to fostering an environment where diversity and inclusion are valued and prioritized. We believe that diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth. As a visionary sensor systems lead, you'll be part of a dynamic team working in a fun, diverse atmosphere. With a compensation plan that...

Unleash Your Career with CalyxoCalyxo, a pioneering medical device company, is seeking an accomplished Product Monitoring Operations Lead to join our dynamic team in Pleasanton, California. As a leader in the field of kidney stone treatment, we're committed to empowering innovators who share our vision for a brighter future.We offer a competitive salary of...

Job OverviewWe are seeking a highly skilled Quality Assurance Director to join our team at Crystal Pharmatech.The successful candidate will be responsible for ensuring compliance with Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP) regulations in our nonclinical laboratory study.Main Responsibilities:Inspection Management: Host...