Description: Our client is currently seeking a Senior Specialist, RAQA for an 18 month contract.
Co-ordinates and prepares document packages for regulatory submissions from all areas of the organization. Collects all materials required in submissions, license renewal, and annual registrations. Keeps abreast of regulatory procedures and changes. May interact with regulatory agencies. Works on problems of complex scope where data analysis requires evaluation of specific factors. Utilizes independent judgment within broad parameters to determine an appropriate solution. May determine methods and procedures on new projects and may provide guidance to other lower-level staff. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 2 or more years experience.
Quality Systems Integration Specialist Seeking a dedicated contractor to support integration activities between our existing company and a recently acquired company, specializing in software and AI-focused products. This role will be central to our Quality and Regulatory teams, with a primary focus on integrating the Quality Management Systems (QMS) of the two organizations to ensure compliance with relevant industry standards and regulations.
Key Responsibilities:
• Support the integration of Quality Systems between our company and the acquired organization, with a specific focus on regulatory and quality compliance for software/AI products.
• Collaborate with cross-functional teams from both companies to align Quality System policies, processes, and procedures, ensuring consistent and effective integration.
• Assess existing Quality Systems and develop integration plans that address gaps, with special attention to software/AI product requirements.
• Support compliance with regulatory standards such as ISO 13485, 21 CFR Part 820, and other relevant regulations specific to software and AI in the medical device space.
• Facilitate risk assessments and gap analyses to identify areas needing improvement or harmonization within the combined Quality Systems.
• Ensure alignment with post-market surveillance and product lifecycle requirements unique to software/AI products.
• Provide regular status updates and integration metrics to stakeholders.
Qualifications:
• Proven experience in Quality Systems management within the medical device industry, particularly with software or AI-driven products.
• Experience in Software Development Lifecyle (SDLC), Software as Medical Device (SaMD) and/or healthcare IT preferred
• Strong understanding of regulatory standards, including ISO 13485, 21 CFR Part 820, and other applicable software/AI regulations.
• Demonstrated experience in managing Quality System integrations post-acquisition.
• Excellent communication and project management skills, with the ability to work cross-functionally and facilitate effective collaboration between teams.
• Ability to analyze complex Quality System structures and recommend practical integration strategies. This contractor role offers the opportunity to play a vital part in our organization's growth and innovation, ensuring a seamless and compliant integration of Quality Systems across both companies.
Contact: eronan@judge.com
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