In collaboration with software engineering teams, clinical teams, and external advisors, develop and maintain quality management system SOP’s, records, and forms for an international SaMD development company located in Los Angeles, CA. 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. This position reports to the Chief Compliance Officer and is fully remote.
Responsibilities:
- The continuous improvement of our Information Security and Quality Management Systems
- Champion data protection efforts
- Maintain and update the corporate knowledge of the relevant Medical Device, Information Security and Data Protection regulations and standards such as 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 the core assurance and compliance activities with respect to those regulations and standards, including leading internal audits, preparing management review, and interactions with notified bodies and competent authority developing regulatory strategy
- Ensure processes are followed at all times for design & development, CAPA, PMS & more.
- Monitor changes in the evolving regulatory landscape to ensure the company remains both compliant and innovative
- Developing and defining the requirements and the processes for preparing technical and regulatory documentation and submissions and managing the international regulatory submission process
- Working with department managers and leads to shape and deliver complex transformation programmes
- Developing and driving the strategic roadmap for business processes, policies, and procedures
- Monitor effectiveness and efficiency of processes. Identify areas for improvement and implement updates
- Effectively communicate plans, priorities, and progress to stakeholders
- Ensuring that post-market obligations are met, and compliance with the requirements for submission of vigilance reports
- Advising clinical evaluations and clinical investigations in accordance with the MDD, MDR, MDCG, MEDDEV and ISO 14155.
- Ensuring that related training is provided where needed to comply with relevant industry standards, medical device requirements, and internal policies and procedures
- The continuous improvement of customer communications and processes to enable product adoption
- Public engagement and external communications on use of healthcare data for patient benefit
- Other corporate compliance requirements and developing company approach as necessary
Qualifications:
- BS/MS (or equivalent) in a scientific discipline and at least 2 years of regulatory/compliance experience
- Experience preparing, submitting, and maintaining CAPA’s for medical device QMS
- Knowledge of ISO 13485:2016 and ISO 49001 standards
- Familiar with use of Atlassian Confluence software
- Familiar with IEC 62304 life cycle requirements for the development of software medical devices
- Experience with US and international regulatory agency interactions and post market reporting
- Experience with MDSAP requirements documentation
- Knowledgeable regarding US FDA & EU MDR regulations
- Excellent written and interpersonal communication skills
