Testimonials
"Tanya joined Arineta at a critical juncture and quickly became an essential member of our executive team. She took full ownership of our global Quality and Regulatory functions, aligning R&D, Manufacturing, Service, and external suppliers to ensure compliance across the entire product lifecycle. Her ability to navigate complex FDA submissions and secure licenses in the U.S., EU, China, Canada, and Australia was pivotal to our market access. I had full confidence in Tanya’s oversight; she consistently met our regulatory and quality commitments while aligning technical mastery with business strategy."
Scott Schubert / Former CEO, Arineta Inc.
"Tanya is a standout expert in global quality systems. During our time at Johnson & Johnson, she mastered the complexities of audits, global vigilance, and complaints handling with a strategic mindset. Tanya was the driving force behind our Computerized System Validation (CSV) and configuration control, ensuring our digital infrastructure remained both compliant and efficient. Beyond her technical proficiency, she possesses a unique ability to interpret complex regulatory requirements and implement custom-fit compliance strategies tailored to the specific scale of any organization. Whether leading critical quality initiatives, or securing worldwide approvals, her leadership is a significant asset."
Vadim Kastin / VP of Q&R, Vectorious Medical Technologies
"Tanya Shalem’s regulatory and quality expertise has been foundational to our success for over seven years. She successfully navigated our 510(k) submissions for Deep Learning Image Reconstruction Algorithms, Wide Field of View CT configurations, and new Lung Screening indications, proving her ability to leverage the right resources to secure critical clearances for the US market. Her leadership extends to global markets, where she led the regulatory strategy and execution for EU MDR and NMPA submissions. On the quality front, she established a robust, effective and efficient QMS that consistently passes rigorous Notified Body ISO 13485, MDSAP, and EU MDR audits. She is a persistent, resourceful leader who delivers results in even the most complex regulatory environments."
Shlomo Seesam / CTO, Arineta Ltd
"Having audited Tanya’s systems for years, I can attest to her expertise in ISO 13485, FDA, EU MDR, and MDSAP. She ensures QMS readiness is a continuous state, scaling quality frameworks to meet company growth without sacrificing rigor. Tanya translates complex requirements into actionable execution with professional integrity. She doesn’t just build systems to pass inspections; she builds them to ensure product safety and organizational excellence."