Global Quality Assurance & Compliance Associate - Digital Health

ABOUT ALIRA HEALTH

At Alira Health, our mission is to enable healthcare transformation. Our team collaborates fully to understand every aspect of each client’s organization from concept ideation to commercial realization, from innovation to implementation. We support our clients with a full spectrum of patient-centric data and tech enabled services including Transaction Advisory, Management Consulting, Real-World Evidence, Advanced Analytics, Patient Engagement, Product Development, Regulatory, Clinical and Market Access.

Our clients are global, and so are we. Our local presence and global collaboration allow us to deliver actionable business insights and an unmatched continuum of support across the full corporate and product lifecycle. We operate across thirteen offices located in Boston and San Francisco in the US; Barcelona, Basel, Bologna, Geneva, Milan, Munich, Paris and Verona in Europe; Cambridge, United Kingdom; Sydney, Australia; and Toronto, Canada.

THE GLOBAL QUALITY ASSURANCE & COMPLIANCE ASSOCIATE

The Global Quality Assurance & Compliance Associate - Digital Health is an important member of the Alira Health team. The Associate works closely with the Quality Assurance & Compliance team to support the implementation and maintenance of the quality management system (QMS), the management of internal and external audit programs, and training compliance.

ESSENTIAL JOB FUNCTIONS

Operational

• Assists the Director and Managers, Global Quality Assurance & Compliance - Digital Health in the implementation of the Quality Policy and QMS
• Manages and tracks training documentation and compliance
• Organizes and maintains QMS and product records and archives
• Serves as audits coordinator and participates in the preparation for, hosting, and response to Sponsor and ISO surveillance audits and regulatory inspections
• Supports QA staff in the investigation and documentation of quality and compliance issues, including audit findings
• Supports the integration of risk management and usability activities in the product life cycle and the implementation of risk mitigation strategies based on quality review outcomes
• Facilitates and ensures training compliance through the planning, preparation and conduct of training
• Ensures and confirms that design and development activities (including design changes) are carried out and documented per applicable requirements and internal procedures
• Supports post-market surveillance and vigilance activities related to digital products, connecting with other departments and functions to collect data and prepare reports
• Creates validation plans for regulated software tools and collaborates in their execution
• Draws up, collects and maintains technical documentation required by the European Medical Device Directive (MDD) and Medical Device Regulation (MDR)
• Assists Global Quality Assurance & Compliance staff in the preparation of internal documents and reports required by Alira Health procedures
• Collects and aggregates quality metrics data, and assists in the coordination, planning and reporting of management reviews of the QMS
• Participates in internal meetings as required

Strategic

• Maintains clear and regular communication with QA and other staff
• Responds to inquiries from staff efficiently and effectively
• Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, ISO standards and company SOPs
• Performs additional duties as assigned

• BS from an undergraduate program or equivalent experience in engineering, software development or a related field
• A minimum of 2 years of experience in the medical device or software development industry
• Prior experience with computer systems validation (CSV) and software as medical device (SAMD)
• Basic knowledge of standards and regulations relevant to medical devices such as ISO 9001, ISO 13485, ISO 14971, ISO 27001, IEC 62304, IEC 62366, MDD, MDR and 21 CFR 820
• Basic knowledge of the computer systems validation process and regulatory requirements relevant to the use of electronic records and signatures, such as 21 CFR Part 11Awareness of data protection laws and regulations, such as GDPR, CCPA, HIPAA and EU Directives
• General understanding of the medical industry and the clinical development process
• Awareness of regulations and guidelines relevant to the conduct of clinical investigations, such as ICH GCP
• Ability to be careful, thorough, and detail-oriented
• Ability to multi-task and work effectively in a fast-paced environment
• Fluent in English, both written and verbal; fluency in Italian and/or French a plus
• Strong communication and interpersonal skills
• Proficient with MS Office Suite, particularly Word, Excel and SharePoint/Teams

LOCATION
Any location in the CET timezone can be considered

The position is 100% remote