Staff Regulatory Affairs Specialist

Analog Devices

  • Valencia
  • Permanente
  • Tiempo completo
  • Hace 29 días
About Analog DevicesAnalog Devices, Inc. (NASDAQ: ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $9 billion in FY24 and approximately 24,000 people globally, ADI ensures today's innovators stay Ahead of What's Possible™. Learn more at and on and .Summary of the Role/About the Team & OrgADI’s Medical Products Group is developing novel remote monitoring solutions that improve patient care and quality of life. The Medical Products Group is looking for an energetic Staff Regulatory Affairs Specialist for the development of novel solutions.Specific Responsibilities / Duties
  • Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering FDA regulations
  • Prepare Pre-Sub and 510(k) submissions and technical documents to support CE mark and other international submissions
  • Ensure that all requirements are met for the Product Lifecycle Process, Risk Management, Design Controls, and Usability Testing
  • Work in fast-paced cross-functional teams to maintain and support quality-engineering methodologies, systems, and practices that meet company, customer, and regulatory requirements
  • Provide quality and compliance input to project teams for decisions and deliverables (e.g., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling)
  • Support Risk Management planning, updating and maintenance of the product risk documentation in compliance with regulatory standards
  • Participate in negotiations and interactions with regulatory authorities during the development and review process
  • Support international product registrations as needed
  • Manage multiple projects and prioritize tasks on day-by-day basis to meet project schedules
  • Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities
  • Review promotional and advertising material
  • Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards
  • Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements
  • Participate in internal and external audits as needed
  • Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements
  • Ensure compliance with design controls in accordance with ISO 13485 standard and 21 CFR 820 regulation.
  • Manage Internal Audit program in accordance with ISO 13485 and MDSAP and host all 3rd party audits including FDA.
  • Provide training of QMS processes
  • Perform other duties as assigned or required
Previous Experience/Skills Needed & Education RequirementsMS Regulatory AffairsExperience with ISO 13485, MDSAP and FDA QSRShould be willing to learn & shouldn’t be afraid of getting their hands dirty!For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls. As such, applicants for this position – except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) – may have to go through an export licensing review process.Analog Devices is an equal opportunity employer. We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group.Job Req Type: ExperiencedRequired Travel: Yes, 10% of the timeShift Type: 1st Shift/Days

Analog Devices