Marcella Garcia Email & Phone Number

Boston, Ma, Us

Burlington, Massachusetts, Us

Pune, Maharashtra, In

San Francisco, Us

Lead global Regulatory Affairs and Quality Assurance activities (Breakthrough Device Designation request, pre submission meetings, 510k submissions) for commercialization of digital AI-diagnostic software-as-a-medical-device (SaMD) for timely and accessible screening for a range of diseases.Submitted a SaMD product for mobile to the Saudi FDA. Pending approval. Achieved SOC 2 Type 2 third party audit from the ground up covering four out of five trust criteria and resulting in one exception out of 250 tested controls.Achieved ISO 13485 certification from the ground up by leveraging the SOC 2 Type 2 foundation to reduce duplication of efforts.

Satellite Beach, Florida, Us

Designing and delivering custom “right sized” solutions for executive teams at early stage start ups in the medical device and digital health space. Regulatory strategy, FDA, SaMD, QMS, compliance, HIPAA, risk management, and information security.

South Orange, Nj, Us

Nia Therapeutics is developing precision brain stimulation therapies to treat memory loss due to brain injury and degenerative disease. Nia’s technology was developed at the University of Pennsylvania with funding from DARPA.

Dedham, Massachusetts, Us

Transformed the Information Security program in six months to achieve HITRUST certification. Building an AL/ML focused QMS from the ground up in 2022 with a focus on authoring core business processes, driving best practices around design controls and V&V. Creating regulatory strategies and advising on regulatory pathways that align with the product roadmap and company vision.

New York, Us

Reporting to C-Suite, lead the cross functional product team in design controls, V&V, and regulatory pathway guidance during COVID. Worked with IT to achieve HITRUST certification. Provided leadership to the Clinical team for CRO selection and procedures compliant to ISO 14155.

Waltham, Massachusetts, Us

Working with partners worldwide to develop innovative technology in the fields of particle therapy, industrial control, scientific research.Reporting to the C-Suite, built the Regulatory and Quality organization from the ground up. Collaborated with one of the world’s leading providers of proton therapy systems on multiple international installations. Worked closely with other proton therapy providers to ensure FDA submissions and risk management activities. Lead all audit activities both internal and supplier facing.

Round Rock, Texas, Us

Lead product development for LCDs used in laptops. Worked with major suppliers and multiple OEMs in Taiwan, Korea, and Japan to ensure successful product launches for Dell. Achieved a green belt in process improvement for creating a program that offset internal testing burden and allowed for major suppliers to promise significantly higher volumes at launch. Worked closely with the launch of the Dell Taiwan Design Center offices.