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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
Bay Labs is at the forefront of bringing deep learning advances to critical unsolved healthcare problems. We have gathered an extraordinary team of clinicians, engineers, and scientists who are developing breakthrough technologies in cardiovascular imaging and care addressing the largest cause of death in the US. The Bay Labs team brings diverse expertise to the problem of diagnosing and treating heart disease with leaders in machine learning, visual neuroscience, robotics, and physics. We have teamed up with a network of world-renowned clinical and academic advisors, progressing in a very short period of time. Current investors in Bay Labs are recognized leaders in venture capital.
This position offers a visionary, high-energy, and hands-on Regulatory Affairs and Quality Assurance expert the opportunity to take a major role in a dynamic early-stage company, working with a great group of people to advance the treatment of heart disease. The person we seek will demonstrate a deep understanding of the quality system and regulatory requirements for medical devices and software, a strong teamwork ethic, and an ability to build business processes that meet international compliance standards while maintaining a high-powered, efficient, technical organization. He or she will play a vital role in launching our products to market and ensuring that they provide the quality, reliability, and accuracy needed by our patients and customers.
Minimum seven years of experience in medical device/software quality assurance and/or regulatory affairs.
Hands-on experience developing successful 510(k) submissions and CE Mark for medical technology products, including clinical testing and plans.
Bachelor’s degree in a scientific discipline or technical field, or equivalent.
Confirmed ability to work in a dynamic entrepreneurial environment where job descriptions are not narrow and all team members take an expansive view of their individual responsibilities.
Ability to exercise independent judgement in devising regulatory plans and actions.
Experience handling regulated medical technology products with significant software components. Experience mapping software development processes to meet FDA and IEC/ISO requirements while using agile methodologies highly desirable.
Deep and current understanding of worldwide quality system and regulatory requirements for medical technology and devices, including FDA CFR 21Part820, ISO 13485, MDD 93/42/EEC, ISO 14971, IEC 62304, AAMI TIR45, and IEC 62366-1, among others.
Excellent writing and communications skills with a highly analytical, detail-oriented approach to solving complex problems.
Experience with heart disease products or cardiovascular technologies is highly desirable.
Working knowledge of medical imaging a plus.
Extensive experience with Part 11-compliant Product Lifecycle Management software such as Oracle Agile. Experience as an administrator highly desirable.
Experience as Management Representative for FDA and Notified Body audits and experience conducting internal audits.
You will develop and implement a full FDA QSR and ISO 13485-compliant quality system, crafting and running procedures and policies that meet the requirements of our target markets.
You will plan and lead regulatory affairs, including preparing submissions for clearances and registrations.
You will serve as liaison with government and regulatory officials in obtaining product approvals.
You will provide leadership and training programs for the organization to ensure that colleagues integrate quality system methods into product development.
You will lead product engineering programs to ensure that development plans and efforts, incorporating the necessary design controls to produce extraordinary products meeting regulatory standards.
You will work with the team and external clinical advisors to craft regulatory and test plans that provide the necessary clinical validation of company technologies.
You will serve as Management Representative to quality and regulatory bodies, including third party auditors.
You will maintain an active effort to stay current with the changes taking place to applicable global standards and regulations.
You will be working very closely with company engineers to provide informed, creative, and effective solutions to the many challenges the team faces in getting products through to commercial release.
You will develop management metrics for evaluating and monitoring the effectiveness of the quality system.
Bay Labs is at the forefront of bringing deep learning advances to critical unsolved healthcare problems. We have gathered an extraordinary team of clinicians, engineers, and scientists who are developing breakthrough technologies in cardiovascular imaging and care, addressing the largest cause of death in the US. The Bay Labs team brings diverse expertise to the problem of diagnosing and treating... heart disease with leaders in machine learning, visual neuroscience, robotics, and physics. We have teamed up with a network of world-renowned clinical and academic advisors, making great progress in a very short period of time. Current investors in Bay Labs are recognized leaders in venture capital