Regulatory Compliance Manager

1 week ago

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

Pearl 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 experienced professional to join our team as a Regulatory Compliance Manager. As a key member of our compliance team, you will play a pivotal role in ensuring our products meet the highest safety and efficacy standards globally.

Key Responsibilities
  • Enhance Information Security and Quality Management Systems through iterative improvements.
  • Ensure compliance with relevant regulations and lead data protection efforts, safeguarding sensitive information and maintaining the trust of our stakeholders.
  • Maintain in-depth knowledge of key regulations and standards, including ISO 13485, FDA regulations, EU Medical Device Directive, ISO 27001, GDPR, and HIPAA.
  • Oversee compliance activities, including internal audits and regulatory interactions, to ensure seamless operations and minimize risk.
  • Develop strategic regulatory plans to support product development and approvals, driving business growth and expansion.
  • Monitor regulatory changes and drive innovation while ensuring compliance, staying ahead of the curve in a rapidly evolving landscape.
  • Develop comprehensive documentation for regulatory submissions and manage the submission process, ensuring accuracy and efficiency.
  • Collaborate with cross-functional teams to drive transformation programs and process improvements, fostering a culture of excellence and continuous learning.
  • Communicate effectively with stakeholders on plans and progress, providing transparent and timely updates.
  • Ensure post-market obligations are met, including vigilance reporting, to maintain a strong reputation and build trust with our customers.
  • Provide guidance on clinical evaluations and investigations according to regulatory requirements, ensuring compliance and accuracy.
  • Facilitate training to ensure compliance with standards and internal policies, empowering our team members to excel in their roles.
  • Improve customer communications and processes for better product adoption, driving business growth and customer satisfaction.
  • Engage with stakeholders on the use of healthcare data for patient benefit, promoting transparency and trust.
  • Address corporate compliance requirements and develop necessary approaches, ensuring a strong foundation for our organization.
Requirements
  • BS/MS in a scientific discipline with at least four years of experience in regulatory affairs or quality management systems for medical devices.
  • Experience in preparing and maintaining CAPAs for medical device QMS.
  • Knowledge of ISO 13485 and ISO 14971 standards.
  • Experience with regulatory agency interactions and post-market reporting.
  • Familiarity with MDSAP requirements documentation.
  • Understanding of FDA and EU regulations.
  • Excellent written and interpersonal communication skills.

*Note, this position is open to remote candidates in certain states or those willing to relocate.

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