Global Regulatory Lead, Device Development

3 weeks ago


Irvine, California, United States Allergan Aesthetics Full time
Job Description

We are seeking a Global Regulatory Lead, Device Development to join our team at Allergan Aesthetics. This role will be responsible for representing regulatory affairs for device development and/or marketed product projects.

Responsibilities
  • Develops regulatory strategic plans to Global Regulatory Lead (GRL) and project teams.
  • Ensures that applications are executed appropriately and submitted on time.
  • Directs communication and interactions with US FDA/Notified Bodies, as primary contact for related projects.
Qualifications
  • Education equivalent to a BS degree in a scientific field, plus 8 years' experience in regulatory affairs; or
  • Education equivalent to a MS degree in a scientific field, plus 6 years' experience in regulatory affairs; or
  • Education equivalent to a PhD degree in a scientific field, plus 4 years' experience in regulatory affairs.
  • Experience in US medical devices regulatory affairs is necessary.

The estimated salary for this position is $160,000 - $220,000 per year, depending on location and qualifications.

About Our Company

Allergan Aesthetics is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.



  • Irvine, California, United States Allergan Aesthetics Full time

    At Allergan Aesthetics, we strive to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.SalaryWe offer a competitive salary range of $115,000 - $150,000 per year, based on experience and qualifications.About the JobThe Sr Manager Regulatory Affairs represents...


  • Irvine, California, United States Entegee Full time

    Job OverviewWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Entegee. In this role, you will be responsible for managing submission publishing, device listings, and UDI data collection in the US and EU markets.The ideal candidate will have 3-4 years of experience in Regulatory Operations within the medical device industry....


  • Irvine, California, United States Entegee Full time

    This is a key role in our organization where you will manage submission publishing, device listings, UDI data collection, and maintain regulatory compliance for medical devices in the US and EU markets.The ideal candidate will have 3-4 years of experience in Regulatory Operations within the medical device industry, a Bachelor's Degree, and expertise with...


  • Irvine, California, United States TP-Link Systems Inc. Full time

    Job OverviewTP-Link Systems Inc. is a global provider of reliable networking devices and smart home products, consistently ranked as the world's top provider of Wi-Fi devices. As a Senior Hardware Development Lead, you will play a critical role in driving the development of innovative hardware solutions for our consumer network and electronic products.Key...


  • Irvine, California, United States Cordis Full time

    Job ResponsibilitiesLead and oversee the design and development of innovative medical devices from concept to commercialization, ensuring adherence to project timelines, budget, and regulatory requirements.Work closely with cross-functional teams to define product requirements and develop robust project plans.Utilize your deep understanding of medical device...


  • Irvine, California, United States Saxon Global Full time

    Job OverviewSaxon Global is seeking a skilled Packaging Expert Leader to manage medical device packaging projects and lead offshore engineering resources.About the RoleThis key position involves overseeing medical device packaging projects from concept to implementation, leading and managing offshore packaging engineering resources, and collaborating with...


  • Irvine, California, United States Nihon Kohden Full time

    Quality and Regulatory Compliance ExpertWe seek a highly experienced Quality and Regulatory Compliance Expert to join our team at Nihon Kohden America. This role offers a salary range of $108,000 to $145,000 based on experience and location.Key ResponsibilitiesLead product quality assurance, quality engineering, and electrical engineering activities.Work...


  • Irvine, California, United States Aerotek Full time

    Job DescriptionAerotek is seeking an experienced Medical Device Assembler to join our team. This is a Contract-to-Hire position with a duration of 6 Months, working fully on-site in Irvine, California.About the RoleThe successful candidate will work under direct supervision using a variety of tools, fixtures, work instructions, and test equipment to perform...


  • Irvine, California, United States TP-Link Systems Inc. Full time

    About TP-Link Systems Inc.We are a leading global provider of networking devices and smart home products, headquartered in the United States. Our mission is to design reliable, high-performance products that connect users worldwide to the limitless possibilities of technology.


  • Irvine, California, United States Pharmavise Corporation Full time

    About the RoleWe are seeking a highly skilled Senior Packaging Engineer to join our team in Irvine, CA. This is a hybrid contract position with a duration of 12 months.Job SummaryThe successful candidate will be responsible for the development and analysis of packaging solutions for medical devices. This includes collaborating with cross-functional teams to...


  • Irvine, California, United States Xe Full time

    About XeXe is a global leader in processing secure electronic financial transactions, providing a range of currency services and solutions to individuals and businesses worldwide.Job DescriptionThis role involves supporting the Deputy Head of Global Compliance in implementing and overseeing the global Compliance regime, ensuring regulatory filings are...


  • Irvine, California, United States TP-Link Systems Inc. Full time

    Role SummaryWe are seeking an experienced Board-Level Hardware Design Engineer to join our systems engineering team. In this role, you will support consumer network and electronic products, conduct needs analysis and design feasibility assessments, complete hardware architecture designs and reviews, and lead the system and board-level design and development...


  • Irvine, California, United States TP-Link Systems Inc. Full time

    TP-Link Systems Inc.We are a global provider of reliable networking devices and smart home products, consistently ranked as the world's top provider of Wi-Fi devices. Our company is committed to delivering innovative products that enhance people's lives through faster, more reliable connectivity.As a Senior HR Business Partner at TP-Link Systems Inc., you...


  • Irvine, California, United States TP-Link Systems Inc. Full time

    Company OverviewTP-Link Systems Inc. is a leading provider of reliable networking devices and smart home products, consistently ranked as the world's top provider of Wi-Fi devices.The company is committed to delivering innovative products that enhance people's lives through faster, more reliable connectivity. With a commitment to excellence, TP-Link Systems...


  • Irvine, California, United States SysMind Tech Full time

    Description of Job SysMind Tech is looking for a qualified Regulatory Affairs Manager to oversee our regulatory compliance efforts. This role requires a high level of expertise in regulatory affairs, quality assurance, and compliance, with a focus on the Medical Device industry.Responsibilities: * Develop and maintain relationships with regulatory agencies,...


  • Irvine, California, United States Kelly Full time

    About KellyJohnson & Johnson is a leading healthcare company with a rapidly expanding R&D division in Irvine, California.Job SummaryWe are seeking a skilled Device Development Specialist to join our team. This full-time position offers excellent career opportunities and job stability.Key ResponsibilitiesAssemble medical devices in the prototype phase.Follow...


  • Irvine, California, United States AbbVie Full time

    About UsAbbVie is a global leader in the development and delivery of innovative medicines and solutions that solve serious health issues. Our mission is to discover and deliver life-changing treatments that transform people's lives.Your RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. In this role, you will be responsible...


  • Irvine, California, United States Nihon Kohden Full time

    Senior Medical Device EngineerWe have an exciting opportunity for a Sr Medical Device Engineer to join our team at Nihon Kohden America. This role offers a competitive salary range of $108,000 to $145,000 based on experience and location.Job ResponsibilitiesConduct all engineering activities in compliance with FDA Regulations, ISO 13485, and other national...


  • Irvine, California, United States Kelly Full time

    **Job Title:** Medical Device Project Coordinator SpecialistAt Kelly Services, we're seeking a skilled Medical Device Project Coordinator Specialist to join our team. This role offers an exciting opportunity to contribute to the development of life-saving medical technologies in the electrophysiology catheter and medical device manufacturing space.As a...


  • Irvine, California, United States Pharmavise Full time

    About the RoleWe are looking for a talented Packaging Engineer to contribute to the development of innovative packaging solutions for medical devices. As a key member of our team, you will be responsible for designing, testing, and analyzing packaging materials and systems to ensure compliance with regulatory requirements and industry standards.Key...