Regulatory Compliance Manager

6 days ago

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

Pearl 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 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.
  • Serve as a champion for 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.

*Note, 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 Manager

    1 week 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 Lead

    1 week 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

    2 weeks 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

    2 weeks ago

    Salt Lake, Utah, United States PacifiCorp Full time

    Customer Regulatory Analyst Company: PacifiCorp Overview PacifiCorp is dedicated to fostering a culture that prioritizes customer service excellence, environmental stewardship, and a commitment to diversity, equity, and inclusion.Role Summary This position involves assisting in the preparation and defense of regulatory submissions related to company...

  • Regulatory Compliance Analyst

    2 weeks ago

    Salt Lake, Utah, United States PacifiCorp Full time

    Customer Regulatory Analyst Company: PacifiCorp Overview PacifiCorp is dedicated to fostering a culture that prioritizes customer service excellence, environmental stewardship, and a commitment to diversity, equity, and inclusion.Role Summary This position involves assisting in the preparation and defense of regulatory submissions concerning company...

  • Regulatory Compliance Analyst

    2 weeks ago

    Salt Lake, Utah, United States PacifiCorp Full time

    Customer Regulatory AnalystCompany: PacifiCorp OverviewPacifiCorp is dedicated to fostering a culture centered around exceptional customer service, environmental stewardship, and inclusivity.Primary Responsibilities • Assist in the formulation and defense of regulatory submissions concerning corporate policies and guidelines, under supervision.• Act as a...

  • Regulatory Compliance Specialist

    1 week 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

    1 week 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 Analyst

    2 weeks 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 Analyst

    2 weeks ago

    Salt Lake, Utah, United States PacifiCorp Full time

    Customer Regulatory Analyst Company: PacifiCorp Overview PacifiCorp is committed to fostering a culture centered around customer service excellence, environmental stewardship, and inclusivity.Position Summary This role involves assisting in the preparation and defense of regulatory submissions concerning company policies and regulations. You will engage...

  • Regulatory Compliance Counsel

    2 weeks 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 Compliance Analyst

    2 weeks ago

    Salt Lake, Utah, United States PacifiCorp Full time

    Customer Regulatory AnalystLocation: RemoteCompany: PacifiCorpOverviewPacifiCorp is dedicated to fostering a culture that prioritizes customer service excellence, environmental sustainability, and inclusivity.Purpose of the RoleUnder supervision, assist in the development and defense of regulatory submissions pertaining to corporate policies and regulations....

  • Regulatory Compliance Analyst

    2 weeks ago

    Salt Lake, Utah, United States PacifiCorp Full time

    Customer Regulatory Analyst Company: PacifiCorp Overview PacifiCorp is dedicated to fostering a culture centered around exceptional customer service, environmental stewardship, and inclusivity.Primary Responsibilities In this role, you will assist in the preparation and defense of regulatory submissions concerning company policies and regulations. You will...

  • Regulatory Compliance Testing Specialist

    2 weeks 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 Testing Specialist

    1 week 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

    2 weeks 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 Supervisor

    2 weeks ago

    Salt Lake, Utah, United States PosiGen Full time

    Job OverviewPosiGen is dedicated to fulfilling the vision of "Solar for All." In alignment with this mission, our Compliance Team is expanding. We are a compact group committed to fostering ethical practices that uphold our standards while identifying and addressing any behaviors that deviate from these principles. We believe that a supportive and inclusive...

  • Regulatory Compliance Specialist

    2 weeks ago

    Salt Lake, Utah, United States Collabera Full time

    Home Search Jobs Job Description Regulatory Compliance Specialist Contract Type: Temporary Salary: $21.00 Per Hour Client's Sector: Financial Services Position Overview: This role involves ensuring adherence to regulatory standards and practices within the financial domain. Duration: 06 Months Work Arrangement: Hybrid Compensation: $20-$22 hourly...

  • Regulatory Affairs Manager

    2 weeks ago

    Salt Lake, Utah, United States ICU Medical Full time

    Position Overview The Regulatory Affairs Manager plays a crucial role in providing support and direction related to the global and US registration of medical device products. This position involves analyzing regulatory requirements and monitoring deliverables to ensure compliance. The manager will assist in the development and maintenance of...

  • Regulatory Affairs Manager

    7 days ago

    Salt Lake, Utah, United States DSJ Global Full time

    DSJ Global is currently seeking a highly skilled Environmental Compliance Manager to support the growth and success of our industrial composites manufacturing operations in the United States.**Job Summary:**We are looking for an experienced professional to oversee environmental compliance and regulatory affairs for our flagship site in Salt Lake City. The...