Pearl, Inc.
Quality & Regulatory Compliance Manager
Pearl, Inc., Austin, Texas, us, 78716
About PearlPearl is shaping the future of dentistry with a suite of AI solutions developed to establish higher standards of quality and care for patients worldwide. We are an international Software as a Medical Device (SaMD) development company committed to revolutionizing healthcare through innovative technologies⎯with a focus on quality, compliance, and data protection.
We are seeking an experienced Quality & Regulatory Compliance Manager to advance our compliance team's mission of ensuring that our products meet the highest global standards of safety and efficacy.
As the Quality & Regulatory Compliance Manager reporting to the Chief Compliance Officer, you will play a pivotal role in ensuring adherence to regulatory requirements and maintaining the integrity of our quality management system. Collaborating closely with cross-functional teams and external advisors, you will drive continuous improvement initiatives and champion data protection efforts.
In collaboration with software engineering teams, clinical teams, and external advisors, develop and maintain quality management system SOP’s, records, and related forms. Oversee staff training in QMS, HIPAA, and GDPR requirements. Support ongoing regulatory reporting activities, including post market surveillance reporting. Develop and maintain regulatory licensing archives and records. Prepare records and documentation for regulatory audits.
ResponsibilitiesLead 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.
Qualifications
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
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We are seeking an experienced Quality & Regulatory Compliance Manager to advance our compliance team's mission of ensuring that our products meet the highest global standards of safety and efficacy.
As the Quality & Regulatory Compliance Manager reporting to the Chief Compliance Officer, you will play a pivotal role in ensuring adherence to regulatory requirements and maintaining the integrity of our quality management system. Collaborating closely with cross-functional teams and external advisors, you will drive continuous improvement initiatives and champion data protection efforts.
In collaboration with software engineering teams, clinical teams, and external advisors, develop and maintain quality management system SOP’s, records, and related forms. Oversee staff training in QMS, HIPAA, and GDPR requirements. Support ongoing regulatory reporting activities, including post market surveillance reporting. Develop and maintain regulatory licensing archives and records. Prepare records and documentation for regulatory audits.
ResponsibilitiesLead 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.
Qualifications
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
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