Regulatory Affairs Project Manager

2 weeks ago


Santa Clara, California, United States Collabera Full time
Job Overview

Collabera is seeking a highly skilled Regulatory Affairs Project Leader to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to achieve business objectives.

Key Responsibilities

  • Develop and implement regulatory strategies to support business growth and compliance
  • Assist in the preparation and submission of regulatory documents, including 510k submissions and CE Technical Documentation
  • Communicate effectively with internal stakeholders, including management, peers, and commercial teams
  • Manage and track regulatory projects, ensuring timely completion and effective communication of results
  • Collaborate with cross-functional teams to solve problems and communicate regulatory needs

Requirements

  • Bachelor's degree in engineering or science, with a minimum of 3 years of experience in regulatory affairs
  • Strong knowledge of US and/or Canadian regulations, or EU and other international medical device regulations
  • Excellent written and verbal communication skills, with the ability to negotiate, influence, and manage conflict
  • Ability to work effectively in a team environment and manage multiple projects simultaneously

What We Offer

  • A dynamic and collaborative work environment
  • Opportunities for professional growth and development
  • A competitive salary and benefits package


  • Santa Clara, California, United States Tek Support Full time

    Regulatory Affairs Project ManagerWe are seeking a highly skilled Regulatory Affairs Project Manager to oversee and coordinate regulatory activities for our medical devices. The ideal candidate will have a strong background in regulatory affairs and experience with US and international medical device regulations.Key Responsibilities:Develop and implement...


  • Santa Clara, California, United States Collabera Full time

    Job Summary:Collabera is seeking a highly skilled Regulatory Affairs Project Leader to join our team. As a key member of our regulatory team, you will be responsible for managing and tracking broad and strategic projects, communicating effectively in writing crisp briefings and issue analysis, and demonstrating ability to work effectively in a team...


  • Santa Clara, California, United States Intellectt Inc Full time

    Regulatory Affairs Project ManagerAt Intellectt Inc, we are seeking a highly skilled Regulatory Affairs Project Manager to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for medical devices.Key Responsibilities:Support IVDR compliance activities, including creation of...


  • Santa Clara, California, United States Experis Full time

    Regulatory Affairs Project Manager Job DescriptionExperis IT ManpowerGroup is partnering with a leading Medical device organization in the Santa Clara area to fill a Regulatory Affairs Project Manager role. This is an on-site position.Job Responsibilities:Support IVDR compliance activities, including creation of technical files and post-market surveillance...


  • Santa Clara, California, United States Collabera Full time

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Project Leader to join our team at Collabera. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for medical devices.Key Responsibilities:Assist in the development and implementation of regulatory strategies and...


  • Santa Clara, California, United States The Fountain Group Full time

    Regulatory Affairs Project ManagerWe are seeking a highly skilled Regulatory Affairs Project Manager to join our team at The Fountain Group. In this role, you will be responsible for coordinating and planning regulatory strategies and submissions to the FDA and other worldwide regulatory agencies.Key Responsibilities:Coordinate and plan regulatory strategies...


  • Santa Clara, California, United States Collabera Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Project Leader to join our team at Collabera. The successful candidate will be responsible for leading regulatory projects and ensuring compliance with US and international regulations.Key Responsibilities:Develop and implement regulatory strategies and priorities in conjunction with management...


  • Santa Clara, California, United States Intellectt Inc Full time

    Regulatory Affairs SpecialistJoin Intellectt Inc as a Regulatory Affairs Specialist and play a critical role in ensuring the compliance of our medical devices with regulatory agency specifications. As a key member of our team, you will be responsible for performing specialized level work assignments and analyses, preparation, and submission of documentation...


  • Santa Clara, California, United States Shockwave Medical Full time

    Job SummaryThe Principal Regulatory Affairs Specialist at Shockwave Medical is a key member of our team, responsible for ensuring that our medical devices meet regulatory requirements. This role requires a strong understanding of scientific, regulatory, and business issues, as well as excellent communication and project management skills.Key...


  • Santa Clara, California, United States Shockwave Medical Full time

    Job Title: Senior Regulatory Affairs SpecialistShockwave Medical is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our mission is to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through our differentiated and...


  • Santa Clara, California, United States Bayside Solutions Full time

    Job Summary:The position is responsible for providing strategic guidance on CMC regulatory matters and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of pipeline compounds/products.Key Responsibilities:Develop and implement CMC regulatory strategies to support the clinical...


  • Santa Clara, California, United States Shockwave Medical Full time

    Job Title: Senior Regulatory Affairs SpecialistShockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our mission is to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through our differentiated...


  • Santa Clara, California, United States Shockwave Medical Full time

    Job Title: Senior Regulatory Affairs SpecialistShockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our mission is to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through our differentiated...


  • Santa Rosa, California, United States Medtronic Full time

    Job Title: Senior Manager, Regulatory AffairsMedtronic is seeking an experienced Senior Manager of Regulatory Affairs to play a crucial role in the development and execution of global regulatory strategies for innovative transcatheter valve technologies.About the RoleThis is a key leadership position that will oversee a team of professionals and contribute...


  • Santa Rosa, California, United States Medtronic Full time

    Job Title: Senior Manager, Regulatory AffairsMedtronic is seeking an experienced Senior Manager to lead our Regulatory Affairs team in the development and execution of global regulatory strategies for innovative transcatheter valve technologies.About the RoleThis is a critical role that will oversee a team of professionals and contribute to the development...


  • Santa Clara, California, United States Collabera Full time

    Job DescriptionCollabera is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory department, you will play a critical role in ensuring efficient and compliant business processes and environment.Key Responsibilities:Support the regulatory department in ensuring compliance with regulatory requirementsAssist...


  • Santa Clara, California, United States Bayside Solutions Full time

    Job Title: Director, CMC Regulatory AffairsAt Bayside Solutions, we are seeking a highly experienced Director, CMC Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance on CMC regulatory strategies and leading the preparation of CMC sections of regulatory...


  • Santa Rosa, California, United States Medtronic Full time

    Job Title: Senior Manager, Regulatory AffairsMedtronic is seeking an experienced Senior Manager of Regulatory Affairs to play a crucial role in the development and execution of global regulatory strategies for innovative transcatheter valve technologies.About the Role:This individual will oversee a team of professionals and contribute to the development of...


  • Santa Monica, California, United States Neogene Therapeutics Full time

    Job Title: Manager, Regulatory AffairsAt Neogene Therapeutics, we are committed to harnessing the power of science to drive innovation and make a meaningful impact on patients' lives. As a Manager, Regulatory Affairs, you will play a critical role in supporting the development and successful performance of our CMC regulatory strategy for our innovative...


  • Santa Clara, California, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott Laboratories 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 MissionWe are committed to...