Regulatory Affairs Director

4 weeks ago


Pleasanton, California, United States BioSpace, Inc. Full time
Job Summary

AbbVie is seeking a highly skilled Regulatory Affairs Director to support the company's Body Contouring devices for marketed products. The successful candidate will be responsible for coordinating and managing global submissions to support renewals, registrations, and new submissions.

Key Responsibilities

Directs and supports the development of the regulatory strategy related to MPS activities for device regulatory activities in various countries, including the US, EU, Japan, and China.

Supports regulatory intelligence and policy activities, monitoring regulatory pathways, legislation updates, policies, and initiatives that could impact marketed products.

Collaborates with regulatory agencies and Notified Bodies, providing leadership and expertise in regulatory operations, change control, lifecycle management, and technical file/design dossier management.

Develops and implements regulatory policies, intelligence interpretation, and strategy for medical devices to support global regulatory plans, due diligence, integrations, and divestitures.

Requirements

Bachelor's degree or equivalent in a scientific discipline.

At least 10 years of regulatory experience in the medical device industry.

Strong knowledge of medical device regulations, including the CE Marking process, global regulatory strategy, and regulatory submission process.

Proven experience in managing relationships with regulatory agency personnel and driving proactive initiatives to ensure compliance.

What We Offer

Competitive compensation package, including a comprehensive benefits program and opportunities for professional growth and development.

Collaborative and dynamic work environment with a team of experienced professionals.

The opportunity to work on challenging projects and contribute to the company's mission to discover and deliver innovative medicines and solutions.

  • Pleasanton, California, United States AbbVie Full time

    Job DescriptionAbbVie is seeking a highly skilled Director of Regulatory Affairs to join our team. As a key member of our regulatory affairs team, you will be responsible for developing and implementing regulatory strategies to support the company's medical device products.Key Responsibilities:Develop and implement regulatory strategies to support the...


  • Pleasanton, California, United States AbbVie Full time

    Job OverviewAbbVie is seeking a highly skilled Director of Regulatory Affairs to support the company's Body Contouring devices for marketed products. The successful candidate will be responsible for coordinating and managing global submissions to support renewals, registrations, and new submissions.The ideal candidate will have a strong background in medical...


  • Pleasanton, California, United States AbbVie Full time

    Regulatory Affairs Director - Body Contouring and Regulatory InnovationAbbVie is committed to delivering innovative medicines and solutions that address serious health issues. As a key member of our team, you will play a critical role in supporting regulatory objectives for our Body Contouring devices.Key Responsibilities:Develop and implement regulatory...


  • Pleasanton, California, United States Accordance Search Group Full time

    Job Title: Principal Regulatory Affairs SpecialistAccordance Search Group is seeking a highly skilled Principal Regulatory Affairs Specialist to join our team in Pleasanton, CA.Job Summary:We are looking for a seasoned regulatory affairs professional to provide strategic support to our regulatory department. The successful candidate will be responsible for...


  • Pleasanton, California, United States BioSpace, Inc. Full time

    Job DetailsCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and...


  • Pleasanton, California, United States EPM Scientific Full time

    Job OverviewWe are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team at EPM Scientific. This is an exciting opportunity to work with a leading medical device and diagnostics company, supporting their growing product portfolio.Key Responsibilities:Develop and implement regulatory strategies for global product approvalsPrepare...


  • Pleasanton, California, United States Abbott Full time

    Job SummaryAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.As a Regulatory Affairs Specialist II, you will play a critical...


  • Pleasanton, California, United States Abbott Laboratories company Full time

    Join Our Team as a Regulatory Affairs Specialist II in Heart FailureAt Abbott, we're committed to helping people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.We're seeking a...


  • Pleasanton, California, United States Abbott Laboratories Full time

    About the RoleAbbott Laboratories is seeking a highly skilled Principal Regulatory Affairs Specialist to join our Heart Failure Division in Pleasanton, CA.As a key member of our regulatory team, you will be responsible for ensuring efficient and compliant business processes and environment. This role involves performing specialized level work assignments...


  • Pleasanton, California, United States Abbott Full time

    About AbbottAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160...


  • Pleasanton, California, United States The Clorox Company Full time

    About the RoleWe are seeking a highly skilled Digital Technology Manager to lead the digital transformation of our Global Stewardship team. This is a key role in driving innovation and efficiency in regulatory processes, ensuring compliance and enhancing data analytics capabilities.Key ResponsibilitiesDevelop and implement a comprehensive digital strategy...


  • Pleasanton, California, United States Abbott Full time

    Job SummaryAbbott is seeking a Regional Sales Director to lead a sales team for the ICM portfolio. The successful candidate will direct strategic programs, market development, and business integrations to maximize revenue growth and profitability of Abbott's CRM Products.This role will support the Western portion of the US, with a preferred location in...


  • Pleasanton, California, United States Abbott Laboratories company Full time

    Job OpportunityAbbott Laboratories is seeking a highly skilled Clinical Research Scientist to join our Heart Failure Division. As a key member of our Global Clinical Affairs team, you will provide scientific expertise to support the development and implementation of clinical evaluations, risk management, and clinical studies.The ideal candidate will have a...


  • Pleasanton, California, United States TAIHO ONCOLOGY INC Full time

    Job SummaryTaiho Oncology Inc. is seeking a highly skilled Strategic Sourcing Leader to join our team. As a key member of our procurement team, you will be responsible for implementing strategic sourcing initiatives to drive cost savings and improve operational efficiency.Key ResponsibilitiesDevelop and implement sourcing strategies for R&D categories,...

  • Treasury Director

    4 weeks ago


    Pleasanton, California, United States Kaiser Permanente Full time

    Job Summary:This position is responsible for directing teams in the completion of complex investment projects requiring advanced knowledge of investment management principles, methods, and techniques in portfolio construction and management, asset allocation, investment policy, performance measurement, accounting principles and practices, and liability...


  • Pleasanton, California, United States Performant Full time

    About Performant:At Performant, we strive to deliver innovative payment accuracy solutions that empower our clients to focus on quality care and healthier lives. As a leading independent healthcare payment integrity company in the US, we serve multiple markets, including Medicare, Medicaid, and Commercial Healthcare.About the Opportunity:Hiring Range:...


  • Pleasanton, California, United States Premise Health Full time

    Health Center Manager RN Job SummaryPremise Health, the world's leading direct healthcare provider, is seeking a Health Center Manager RN to lead site operations at our Workday Wellness Center in Pleasanton, CA. As a key member of our team, you will oversee the management of our health center, providing clinical support and ensuring efficient and effective...


  • Pleasanton, California, United States Premise Health Full time

    About the Role:Premise Health is seeking a Full-time Health Center Manager RN to lead site operations and provide as-needed clinical support at our Workday Wellness Center in Pleasanton, CA.Key Responsibilities:Oversee the overall management of a medium-sized health center with 2+ regularly scheduled employees.Provide a moderate amount of time dedicated to...


  • Pleasanton, California, United States Premise Health Full time

    Healthcare Without RivalPremise Health is the world's leading direct healthcare provider, serving over 11 million eligible lives across more than 2,500 of the largest commercial and municipal employers in the U.S. We partner with our clients to offer fully connected care – in-person and in the digital environment. Our team operates more than 800 onsite and...


  • Pleasanton, United States Accordance Search Group Full time

    Our client is seeking a Principal Regulatory Affairs Specialist for their Pleasanton, CA location.OVERVIEW:As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment. This position performs specialized level work...


  • Pleasanton, United States EPM Scientific Full time

    Title: Principal Regulatory Affairs SpecialistA leading medical device and diagnostics company is seeking a Principal Regulatory Affairs Specialist to support their growing product portfolio. This is an exciting opportunity to join an innovative company working on breakthrough products. Responsibilities:Developing strategies for regulatory approval on a...


  • Pleasanton, Kansas, United States Abbott Laboratories company Full time

    Job SummaryWe are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team at Abbott Laboratories. As a key member of our regulatory department, you will be responsible for ensuring efficient and compliant business processes and environment.Key ResponsibilitiesDevelops worldwide strategies for regulatory approval of new and modified...


  • Pleasanton, United States EPM Scientific Full time

    Job DescriptionJob DescriptionTitle: Principal Regulatory Affairs SpecialistA leading medical device and diagnostics company is seeking a Principal Regulatory Affairs Specialist to support their growing product portfolio. This is an exciting opportunity to join an innovative company working on breakthrough products.Responsibilities:Developing strategies for...

  • Rehab Director

    2 months ago


    Pleasanton, United States Relient Health Full time

    This position requires licensure! You MUST BE a Physical Therapist or Occupational Therapist! Relient Health seeks a Director of Rehab (DOR) / Therapy Program Manager (PT or OT) to work in a great Skilled Nursing Facility (SNF) setting. This opening is for a full-time, permanent position. Interested applicants should desire to create an environment where...

  • Rehab Director

    3 weeks ago


    Pleasanton, United States Relient Health Full time

    This position requires licensure! YouMUST BEa Physical Therapist or Occupational Therapist! Relient Health seeks a Director of Rehab (DOR) / Therapy Program Manager (PT or OT) to work in a great Skilled Nursing Facility (SNF) setting. This opening is for a full-time, permanent position. We are not considering any other disciplines for this...


  • Pleasanton, Kansas, United States Kaiser Permanente Full time

    Job Summary: The Regional Director of Research and Development at Kaiser Permanente leads one of the largest research centers in the country, overseeing an expansive research portfolio with over $130 million in federal, state, industry, and institutionally funded research. This includes epidemiology, delivery science, clinical trials, social and...


  • Pleasanton, United States Kaiser Permanente Full time

    Job Summary: The regional director for the Division of Research leads one of the largest research centers in the country, including an expansive research portfolio, over $130 Million + of federal, state, industry, and institutionally funded research in epidemiology, delivery science, clinical trials, social and health-related disparities, patient-centered...


  • Pleasanton, Kansas, United States Premise Health Full time

    Health Center Manager RN Job DescriptionPremise Health is a leading direct healthcare provider, serving over 11 million eligible lives across the country. We partner with our clients to offer fully connected care, in-person and in the digital environment.As a Health Center Manager RN, you will lead site operations and provide as-needed clinical support. This...

  • Activity Director

    2 weeks ago


    Pleasanton, United States Oakmont Senior Living Full time

    Position: Activity Director Shifts, Time, and Days: Tuesday through Saturday Pay Range: $26.00 to $28.00 Ivy Park at Pleasanton is a premier senior living community situated on a beautifully landscaped campus. Managed by Oakmont Management Group,we provide exceptional quality, comfort, and care with five-star services and amenities. Residents enjoy a...


  • Pleasanton, United States HealthEcareers - Client Full time

    Job Summary: The regional director for the Division of Research leads one of the largest research centers in the country, including an expansive research portfolio, over $130 Million + of federal, state, industry, and institutionally funded research in epidemiology, delivery science, clinical trials, social and health-related disparities, patient-centered...


  • Pleasanton, United States Recruitics JB Full time

    Job Summary: The regional director for the Division of Research leads one of the largest research centers in the country, including an expansive research portfolio, over $130 Million + of federal, state, industry, and institutionally funded research in epidemiology, delivery science, clinical trials, social and health-related disparities, patient-centered...

  • Activity Director

    1 month ago


    Pleasanton, United States Ivy Park at Otay Ranch Full time

    Shifts, Time, and Days: Tuesday through Saturday Pay Range: $26.00 to $28.00 INSERT COMMUNITY NAME is a premier senior living community situated on a beautifully landscaped campus. Managed by Oakmont Management Group, we provide exceptional quality, comfort, and care with five-star services and amenities. Residents enjoy a rewarding lifestyle with...


  • Pleasanton, United States Abbott Laboratories Full time

    MAIN PURPOSE OF ROLE:The Director of Systems Engineering MCS has direct accountability for driving the technical direction of the Systems Engineering group with the Mechanical Circulatory Support R&D group. Responsible for managing the capabilities of the group to ensure business objectives are met as it pertains to systems engineering, new technology and...


  • Pleasanton, United States Performant Full time

    ABOUT PERFORMANT: At Performant, we're focused on helping our clients achieve their goals by providing technology-enabled services which identify improper payments and recoup or prevent losses due to errant billing practices. We are the premier independent healthcare payment integrity company in the US and a leader across several markets, including Medicare,...


  • Pleasanton, Kansas, United States Premise Health Full time

    Job Summary:Premise Health is seeking a skilled Health Center Manager RN to lead site operations and provide clinical support at our Workday Wellness Center in Pleasanton, CA.Key Responsibilities:Oversee the management of a medium-sized health center, including staff supervision and performance management.Provide clinical support and technical expertise as...


  • Pleasanton, CA, United States Kaiser Permanente Full time

    Job Summary: The regional director for the Division of Research leads one of the largest research centers in the country, including an expansive research portfolio, over $130 Million + of federal, state, industry, and institutionally funded research in epidemiology, delivery science, clinical trials, social and health-related disparities, patient-centered...


  • Pleasanton, CA, United States Kaiser Permanente Full time

    Job Summary: The regional director for the Division of Research leads one of the largest research centers in the country, including an expansive research portfolio, over $130 Million + of federal, state, industry, and institutionally funded research in epidemiology, delivery science, clinical trials, social and health-related disparities, patient-centered...

  • Wellness Nurse, LVN

    4 days ago


    Pleasanton, United States Oakmont Management Group Full time

    Position: Wellness Nurse (Hiring for this position must be approved by VP of Health Services PRIOT TO POSTING) Shifts, Time, and Days: Tuesday-Saturday AM Pay Range: $30.00 -$32.00 Hourly Ivy Park at Pleasanton is a premier senior living community situated on a beautifully landscaped campus. Managed by Oakmont Management Group, we provide exceptional...


  • Pleasanton, United States Oakmont Senior Living Full time

    Regional Operations Specialist - RCFE license required Must reside in Northern California. The Regional Operations Specialis t is responsible for the efficient operation and overall management and direction of the day-to-day functions of an assigned Community in accordance with policies and procedures, current standards, guidelines, and regulations....