- Quality Assurance
- Regulatory Reporting
- Information Management
- FDA Regulations
- Clinical Research
7 years of experience leading global regulatory affairs guidance for software-based in medical devices.
3 years of experience providing regulatory advice to teams conducting clinical evaluations.
Experience with compliance requirements for US FDA, MDD/MDR, MEDDEV and Harmonized Standards.
Experience with approval submissions, clinical studies, labelling, pre-market communication, field actions, and QMS compliance.
Degree in medicine/biomedicine or law or engineering (or other relevant scientific discipline).
Experience in SaMD, and collaborating with software engineers.
Knowledge of clinical research methodology, information management and medical writing.
Experience implementing pre-market regulatory strategies for products without clear regulatory precedent.
Experience in the management of quality assurance, product development, or operations.
About the job
Our team includes experts who are leveraging expertise in AI, hardware, products, and more to solve the big challenges in healthcare to help people lead healthier, more productive lives. This team works closely with other groups within Google and across Alphabet.
As a Regulatory Affairs Manager you will serve as a primary interface to regulatory authorities around the globe. In this role, you will regularly communicate with Competent Authorities and other regulatory bodies, support the Health PA teams in correct interpretation of regulation and guidance, develop pre and post market regulatory strategies, and prepare / manage regulatory submissions. You will work closely between Clinical, Regulatory, Research, Partners, Engineering and Legal Teams to lead proactively on all matters for Regulatory Affairs. As one of the most regulated industries, navigating international rules that govern Medical Devices is complex and challenging. Our team is working to deliver regulatory science solutions that ensure that Google Health’s innovative products reach our customers quickly and with the highest levels of quality and compliance.
At Google we’re committed to improving the lives of as many people as possible. One of the most important areas in which we’re striving to do that is health. Today we’re studying the use of artificial intelligence to assist in diagnosing cancer, predicting patient outcomes, preventing blindness, and much more. We’re exploring ways to improve patient care, including tools that are already being used by clinicians. And we’re partnering with doctors, nurses, and other healthcare professionals to help improve the care patients receive.
Develop strategies and submissions for products to gain clearance/approval for global commercial marketing, clinical research and Competent Authority approval.
Develop approaches to human clinical studies, providing guidance and support to ensure compliant trials and ensure industry best-practice ethics.
Lead on post-market surveillance, post-market safety and performance data to support periodic clinical evaluation reports, management review, field actions, adverse event reporting and regulatory reporting to comply with global regulatory requirements.
Supporting product development and labeling development, by keeping up to date regulatory documentation and declarations of conformity, and communicating potential issues/roadblocks regarding regulations and standards.
Review and approve changes to QMS structure and policies, and ensure ongoing performance metric gathering, analysis and review of regulatory activities to ensure programs consistency with industry best practice, and that it meet applicable regulations and standards.
At Google, we don’t just accept difference—we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products and our community. Google is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also Google's EEO Policy and EEO is the Law. If you have a disability or special need that requires accommodation, please let us know by completing this form.