The Privacy and Regulatory Manager will focus on the legal requirements at the intersection of patient privacy, technology and advanced medical data. You are committed to building trust and consensus while enabling privacy driven products and mitigating risk within the global regulatory landscape of GDPR, HIPAA, CCPA and other privacy laws. You will lead the Legal data management operations and act as our Data Protection Officer.
You understand the relationship between relevant regulatory frameworks such as GCP and a fast-moving agile development process. You are a highly structured person, self-starter with attention to detail and you take pride in using your compliance work as an enabler and accelerator for the product and operation teams ensuring any roadblocks are cleared from their path. You will be an integrated part of a passionate and fast-moving company that is providing a state-of-the-art global service.
You do not mind getting your hands dirty and drive first hand the optimization of a well run data privacy framework and Quality Management System
In this role, you will acquire unique competences in enabling entrepreneurship in the medical and pharma industries.
Drive Collective Minds’ framework in the global regulatory landscape of GDPR, HIPAA, CCPA and other privacy laws
- Stay up to date with clinical research related regulatory frameworks, standards, and guidelines, such as GCP, ISO 13485, GAMP 5, 21 CFR Part 11, and Annex 11
- Have ownership of our QMS and continuously optimize it and build in new regulatory requirements
- Run internal reviews, act as an audit frontline and perform vendor assessments
- Train the organization and ensure compliance
Skills And Qualifications
- Extensive experience in leading healthcare or clinical research organizations in regard to global data privacy legislation
- Formal training and practical experience implementing in a few of GCP, ISO 13485, GAMP 5, 21 CFR Part 11, Annex 11, and other relevant frameworks in a software environment
- Experience running Regulatory and Quality compliance processes
- Drive all your work in English
- Relevant certifications
- Contributor to any Special Interest Groups developing privacy or regulatory frameworks
- Experience with SaaS/Subscription-based platforms and cloud environments
- Understanding of agile software development in a regulated industry