Alyssa Haig

The Oriel STAT A MATRIX consulting team averages 25+ years of life sciences industry experience and has deep expertise in US, European and global RA/QA requirements.

Alyssa’s Areas of Expertise

• Regulatory – Handled multiple successful product registrations and approvals (both US and international) for a diverse portfolio of product types in the medical device, IVF, pharmaceutical, consumer, and cosmetic markets. Also successfully mitigated FDA Warning Letters and managed 5 successful FDA inspections across 3 sites. Additionally hosted dozens of successful international regulatory inspections, including MDSAP, US, Canadian, ISO 13485, and EU MDD.
• Quality Management Systems – Has conducted QMS rehabilitation, development, implementation, consolidation, and operation to be compliant with such regulations as 21 CFR 201/211, 21 CFR 820, 21 CFR 58, 21 CFR 700, MDSAP, and ISO 13485.

Highlighted Experience

• Directed a QA/RA team to maintain overall company regulatory compliance for medical device and pharmaceutical quality management systems to achieve FDA preapproval inspection readiness as well as enable a transition to ISO 13485:2016. Also directed this QA/RA team to manage and maintain regulatory approvals worldwide, including submission for a complex Class III medical device as per the EU MDR.
• Developed and executed a QMS implementation plan for compliance to ISO 13485:2016, MDSAP, EU MDR, and 21 CFR 820.
• Interfaced with and monitored product quality from contract manufacturing organizations and GLP test labs, including remote document review and on-site supplier quality audits. Also provided oversight to manufacturing quality assurance operations, including oversight of contract manufacturers of active ingredients and products, ensuring compliance to 21 CFR 210/211 and 21 CFR 820.
• Conducted a complete overhaul of a company’s global QMS to consolidate all locations to one globally compliant system to address compliance challenges, including closing an FDA warning letter, ensuring FTC and CA compliance for consumer products, and conducting subsequent follow-up inspections.
• Secured multiple regulatory approvals for 510(k)s, CE Marking, and Canadian MDLs for a variety of complex active surgical devices for cardiovascular use, as well as sterile animal tissue-based implantable medical devices for soft tissue and dental use, including direct monitoring of GLP studies and GLP labs.