Freenome’s Vice President, Regulatory Affairs & Quality Systems will lead, manage and implement regulatory and quality strategy for the organization. You will join a high impact team that takes innovative approaches to curing age-related disease. We develop new software, technology, science, and medicine with leading experts from each field. If you are interested in building a strong intellectual community and you want to help be a part of treating cancer, come talk to us!
Please apply here! - https://jobs.lever.co/freenome/e8d3acea-e4c6-43cf-a6da-f370e46a5731/apply
- Responsible for development and implementation of product regulatory strategies and plans for submissions to FDA, and other regulatory authorities, as appropriate
- Lead interactions with the FDA, CAP, NYSDOH, and international agency personnel to expedite approval of pending applications and resolve regulatory matters
- Partner with other functional leaders including Quality Assurance, R&D, Clinical Operations, to develop, implement, and improve quality systems
- Ensure compliance with the FDACode of Federal Regulations, the European in Vitro Diagnostic Directives/regulations, EN 13485 and other International Quality Standards as appropriate. This includes, but is not limited to, country specific licenses, the design input, review, out-put and verification, validation, transfer and change control.
- Direct the compilation of device master records, technical files, design dossiers, FDA and European submission documents, and/or any other relate documents/reports, ensuring timely submissions to CDRH, etc., to meet Company product(s) and regulatory requirements, and compliance to all approved licenses.
- Review submissions for completeness, accuracy, verification of analytical and clinical data, and compliance with submission standards and expectations
- Maintain regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment, and regulatory precedent
- Ensure alignment of regulatory strategy to business strategy across all functional areas
- Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans
- Ensure employees understand and comply with the requirements of cGMP as applied to the Company’s product(s). Provide related training and support to departments as needed
- Provide regulatory due diligence and regulatory advice for potential new product opportunities