Quality Assurance Specialist

7 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.

As the Regulatory Compliance Manager, you will be responsible for:

  • Leading the continuous improvement of our Information Security and Quality Management Systems.
  • Serving as a champion for data protection efforts, ensuring compliance with relevant regulations.
  • Maintaining and updating 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.
  • Overseeing core assurance and compliance activities, including internal audits, management review, and interactions with regulatory bodies.
  • Developing and executing regulatory strategies to support product development and market approval.
  • Ensuring adherence to processes related to design & development, CAPA, post-market surveillance, and more.
  • Monitoring changes in the regulatory landscape and driving innovation while maintaining compliance.
  • Developing requirements and processes for regulatory documentation and submissions, managing the international regulatory submission process.
  • Collaborating with department managers to shape and deliver transformation programs.
  • Driving the strategic roadmap for business processes, policies, and procedures.
  • Monitoring process effectiveness and efficiency, identifying areas for improvement and implementing updates.
  • Effectively communicating plans, priorities, and progress to stakeholders.
  • Ensuring post-market obligations are met, including submission of vigilance reports.
  • Providing guidance on clinical evaluations and investigations in accordance with regulatory requirements as per MDD, MDR, MDCG, Meddev and ISO 14155.
  • Facilitating training to ensure compliance with industry standards and internal policies.
  • Driving continuous improvement of customer communications and processes to enhance product adoption.
  • Engaging with the public and external stakeholders on the use of healthcare data for patient benefit.
  • Addressing other corporate compliance requirements and developing 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

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