The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
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Caption Health is looking for a dynamic regulatory and quality leader who is adept at regulatory strategy, leading quality systems across cross-functional teams, and is effective across the full spectrum of startup regulatory and quality needs. The Head of Regulatory and Quality Affairs will lead a team to create and execute the company’s regulatory strategy and support the development and implementation of our quality system. We are looking for a leader to partner with the CEO and leadership team to influence business strategy, drive quality across the organization, and be the company’s external interface to regulatory agencies. This critical and high-profile role will report to the VP Clinical Strategy and Innovation.
The candidate will have hands-on experience and success in setting and executing regulatory strategies for novel technology products. The ideal candidate will have experience in regulations of software as a medical device and experience both domestically and internationally. Additionally, the candidate will have experience in building and implementing quality systems to meet market needs and building high-functioning teams to support both the regulatory and quality functions.
You will plan and lead regulatory affairs, including preparing submissions for clearances and registrations.
You will serve as Management Representative for the company’s FDA QSR and ISO 13485-compliant quality system, responsible for procedures and policies that meet the requirements of our target markets.
You will be a liaison with government and regulatory officials in obtaining product approvals.
You will provide leadership and, with your team, training programs for the organization to ensure that colleagues integrate quality system methods into product development.
You will collaborate with development teams to guarantee that development plans and efforts incorporate the necessary design controls to produce extraordinary products meeting regulatory standards.
You will collaborate with the team and external clinical advisors to craft test plans that provide the necessary clinical validation of company technologies.
You will maintain an active effort to stay current with the changes taking place to applicable global standards and regulations.
You will work very closely with company development teams to provide informed, creative and effective solutions to the many challenges the team faces in getting products through to commercial release.
You will establish management metrics for evaluating and monitoring the effectiveness of the quality system.
You will engage in opportunities for thought leadership of regulation in the field of AI in medicine.
Minimum 8+ years of experience in medical device/software quality assurance and 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 judgment 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, meticulous approach to solving complex problems.
Working knowledge of medical imaging is desirable, and knowledge of machine learning or artificial intelligence is a plus, but not required.
Extensive experience with Part 11-compliant Product Lifecycle Management software such as Oracle Agile. Experience as an administrator is highly desirable.
Experience as Management Representative for FDA and Notified Body audits and experience conducting internal audits.
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About Caption Health
Caption Health is a leading medical artificial intelligence (AI) company driving better health outcomes by increasing access to ultrasound.