Quality and Regulatory Compliance Specialist

7 days ago

Salt Lake, Utah, United States Pearl AI Full time
About Pearl AI

Pearl AI is revolutionizing the future of dentistry with cutting-edge AI solutions that set new standards for quality and care worldwide. As a pioneering Software as a Medical Device (SaMD) development company, we're committed to transforming healthcare through innovative technologies that prioritize quality, compliance, and data protection.

Job Summary

We're seeking an experienced Quality & Regulatory Compliance Manager to drive our compliance team's mission of ensuring our products meet the highest global standards of safety and efficacy. As a key member of our team, you'll play a pivotal role in ensuring adherence to regulatory requirements and maintaining the integrity of our quality management system.

Key Responsibilities
  • Lead the continuous improvement of our Information Security and Quality Management Systems.
  • Champion data protection efforts, ensuring compliance with relevant regulations.
  • Maintain and update corporate knowledge of key regulations and standards, including ISO 13485, FDA CFR Title 21 Part 820, EU Medical Device Directive / Regulation (MDD/MDR), EN/IEC 62304, ISO 14971, ISO 27001, GDPR, and HIPAA.
  • Oversee core assurance and compliance activities, including internal audits, management review, and interactions with regulatory bodies.
  • Develop and execute regulatory strategies to support product development and market approval.
  • Ensure adherence to processes related to design & development, CAPA, post-market surveillance, and more.
  • Monitor changes in the regulatory landscape and drive innovation while maintaining compliance.
  • Develop requirements and processes for regulatory documentation and submissions, managing the international regulatory submission process.
  • Collaborate with department managers to shape and deliver transformation programs.
  • Drive the strategic roadmap for business processes, policies, and procedures.
  • Monitor process effectiveness and efficiency, identifying areas for improvement and implementing updates.
  • Effectively communicate plans, priorities, and progress to stakeholders.
  • Ensure post-market obligations are met, including submission of vigilance reports.
  • Provide guidance on clinical evaluations and investigations in accordance with regulatory requirements as per MDD, MDR, MDCG, Meddev, and ISO 14155.
  • Facilitate training to ensure compliance with industry standards and internal policies.
  • Drive continuous improvement of customer communications and processes to enhance product adoption.
  • Engage with the public and external stakeholders on the use of healthcare data for patient benefit.
  • Address other corporate compliance requirements and develop company approaches as necessary.
Requirements
  • BS/MS (or equivalent) in a scientific discipline and at least four (4) years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
  • Experience in preparing, submitting, and maintaining CAPAs for medical device QMS.
  • Proficiency in ISO 13485:2016 and ISO 14971 standards.
  • Familiarity with Atlassian Confluence software.
  • Knowledge of IEC 62304 life cycle requirements for software medical devices.
  • Experience with US and international regulatory agency interactions and post-market reporting.
  • Familiarity with MDSAP requirements documentation.
  • Understanding of US FDA and EU MDR regulations.
  • Excellent written and interpersonal communication skills.

This position is open to remote candidates in the following states or those willing to relocate: AZ, DE, FL, GA, ID, IN, NC, PA, TX, UT, WI

  • Regulatory Compliance Specialist

    4 weeks ago

    Salt Lake, Utah, United States PacifiCorp Full time

    About the RolePacifiCorp is seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our Customer Care department, you will play a critical role in ensuring compliance with regulatory requirements and providing exceptional customer service.Key ResponsibilitiesPrepare and defend regulatory filings related to company rules...

  • Regulatory Compliance Specialist

    4 weeks ago

    Salt Lake, Utah, United States PacifiCorp Full time

    About the RolePacifiCorp is seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our Customer Care department, you will play a critical role in ensuring compliance with regulatory requirements and providing exceptional customer service.Key ResponsibilitiesPrepare and defend regulatory filings related to company rules...

  • Regulatory Compliance Specialist

    2 weeks ago

    Salt Lake, Utah, United States Pearl AI Full time

    About Pearl AIPearl AI is revolutionizing the future of dentistry with cutting-edge AI solutions that set new standards for quality and care worldwide. As a pioneering Software as a Medical Device (SaMD) development company, we're committed to transforming healthcare through innovative technologies that prioritize quality, compliance, and data...

  • Regulatory Compliance Manager

    4 weeks ago

    Salt Lake, Utah, United States Pearl AI Full time

    About Pearl AIPearl AI is a pioneering company in the field of dentistry, dedicated to harnessing the power of artificial intelligence to revolutionize patient care and elevate quality standards globally. We are committed to driving innovation through cutting-edge solutions that prioritize quality, compliance, and data protection.We are seeking an...

  • Regulatory Compliance Manager

    4 weeks ago

    Salt Lake, Utah, United States Pearl AI Full time

    About Pearl AIPearl AI is a pioneering company in the field of artificial intelligence, dedicated to revolutionizing the healthcare industry with innovative solutions. Our mission is to establish higher standards of quality and care for patients worldwide.We are seeking an experienced Regulatory Compliance Manager to join our compliance team and play a...

  • Regulatory Compliance Testing Specialist

    4 weeks ago

    Salt Lake, Utah, United States First Electronic Bank Full time

    Job OverviewThe Compliance Testing Analyst serves as a crucial component of the Second Line of Defense, tasked with executing compliance assessments to ensure that our Strategic Partners adhere to relevant laws and regulatory standards. This role involves following a structured, risk-based testing strategy for each evaluation, generating comprehensive...

  • Regulatory Compliance Testing Specialist

    1 month ago

    Salt Lake, Utah, United States First Electronic Bank Full time

    Job OverviewThe Compliance Testing Analyst operates as a vital component of the Second Line of Defense, tasked with executing compliance evaluations to assess our Strategic Partner's adherence to relevant laws and regulatory standards. This role involves adhering to a predetermined risk-based testing framework for each assessment, generating comprehensive...

  • Regulatory Compliance Testing Specialist

    1 month ago

    Salt Lake, Utah, United States First Electronic Bank Full time

    Job OverviewThe Compliance Testing Analyst serves as a vital component of the Second Line of Defense, tasked with executing compliance evaluations to assess our Strategic Partner's adherence to relevant laws and regulatory standards. This role involves adhering to a predefined risk-based testing strategy for each assessment, generating comprehensive work...

  • Regulatory Compliance Lead

    4 weeks ago

    Salt Lake, Utah, United States First Electronic Bank Full time

    Regulatory Compliance LeadFirst Electronic Bank is on the lookout for a skilled Regulatory Compliance Lead to enhance their outstanding compliance department. The Regulatory Compliance Lead is vital in upholding the bank's Strategic Partnership engagements by ensuring adherence to contractual obligations and regulatory standards. This role involves close...

  • Regulatory Compliance Analyst

    1 month ago

    Salt Lake, Utah, United States PacifiCorp Full time

    Customer Regulatory AnalystCompany: PacifiCorp OverviewPacifiCorp is dedicated to fostering a culture that prioritizes customer service excellence, environmental stewardship, and a commitment to diversity, equity, and inclusion.Core Responsibilities • Assist in the formulation and defense of regulatory submissions concerning company policies and standards,...

  • Regulatory Compliance Analyst

    1 month ago

    Salt Lake, Utah, United States PacifiCorp Full time

    Customer Regulatory AnalystCompany: PacifiCorp OverviewPacifiCorp is dedicated to fostering a culture that prioritizes customer service excellence, environmental stewardship, and inclusivity.Position SummaryUnder supervision, assist in the formulation and defense of regulatory submissions concerning company policies and standards. Engage with state...

  • Regulatory Compliance Counsel

    1 month ago

    Salt Lake, Utah, United States ComplyAuto Full time

    Job OverviewComplyAuto is a leading RegTech organization that provides innovative cloud-based solutions designed to enhance compliance and security for businesses, while promoting efficiency and cost-effectiveness. Our platform automates compliance decisions, significantly reducing the need for labor-intensive processes and human intervention.Initially...

  • Regulatory Affairs Specialist

    3 weeks ago

    Salt Lake, Utah, United States ICU Medical Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ICU Medical. As a key member of our Global Regulatory Affairs team, you will play a critical role in ensuring the compliance of our device products with global regulations.Key ResponsibilitiesDrive projects forward and execute agreed-upon strategies and plans with...

  • Quality Assurance Specialist

    3 weeks ago

    Salt Lake, Utah, United States Infotree Global Solutions Full time

    Quality Specialist RoleWe are seeking a skilled Quality Specialist to join our team at Infotree Global Solutions in Salt Lake City, UT. This is a key position for a leading medical company, responsible for ensuring the highest quality standards in our products and processes.Key ResponsibilitiesComplaint Handling: Track, investigate, and respond to customer...

  • Quality Assurance Specialist

    3 weeks ago

    Salt Lake, Utah, United States Infotree Global Solutions Full time

    Job SummaryWe are seeking a highly detail-oriented and organized Quality Assurance Specialist to join our team at Infotree Global Solutions. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products.Key ResponsibilitiesPerform Accurate Inspections: Conduct thorough and accurate mechanical,...

  • Environmental Compliance Specialist

    3 days ago

    Salt Lake, Utah, United States Maverik Full time

    Environmental Compliance SpecialistMaverik is seeking a dedicated Environmental Compliance Specialist to play a key role in maintaining and enhancing our Environmental Management System.Key Responsibilities:Manage and oversee Underground Storage Tank (UST) compliance, ensuring all documentation and regulatory requirements are met efficiently.Assist in the...

  • Compliance Specialist Intern

    3 days ago

    Salt Lake, Utah, United States Zions Bank Full time

    Compliance Specialist Intern - Credit Compliance and Strategic InitiativesZions Bancorporation is a leading financial services company operating in high-growth western markets. We are committed to creating a culture that values diversity and promotes a sense of belonging for all team members.About the RoleWe are seeking a highly motivated Compliance...

  • Grant and Compliance Specialist

    9 hours ago

    Salt Lake, Utah, United States The Road Home Full time

    Job Title: Grant and Compliance SpecialistThe Road Home is seeking a highly skilled Grant and Compliance Specialist to join our team. As a key member of our Grants and Compliance department, you will play a critical role in ensuring that our programs are operating in accordance with all grant and funding regulations, as well as our own high-quality...

  • Quality Assurance Specialist

    2 weeks ago

    Salt Lake, Utah, United States Infotree Global Solutions Full time

    Quality Specialist Job DescriptionWe are seeking a highly skilled Quality Specialist to join our team at Infotree Global Solutions in Salt Lake City, UT.Key Responsibilities:Complaint Handling: Track, investigate, and respond to customer complaints in a timely and professional manner.Quality Assurance: Monitor and maintain quality standards for products and...

  • Environmental Compliance Specialist

    3 weeks ago

    Salt Lake, Utah, United States PacifiCorp Full time

    Job SummaryPacifiCorp is seeking a highly skilled Environmental Compliance Specialist to join our team. As an Environmental Compliance Specialist, you will be responsible for ensuring the company's compliance with environmental regulations and laws.Key ResponsibilitiesConduct environmental compliance reviews of electric utility transmission, distribution,...