JESSICA DIANE STAUB
Downingtown
Summary
Dynamic Senior RAQA leader with over 20 years of specialized experience in Class III implantable medical devices, particularly spinal implants. Expertise includes PMA submissions, global registrations, and post-market compliance, along with a proven ability to build and scale robust quality systems. Demonstrated success in leading FDA and international regulatory submissions while fostering cross-functional collaboration to drive innovation, commercialization, and global expansion. In-depth knowledge of PMA supplements, manufacturing changes, MDSAP, and strategic regulatory frameworks across more than 30 countries provides a valuable asset in navigating complex regulatory landscapes.
Overview
21
21
years of professional experience
Work History
Senior Director, Quality & Regulatory Affairs
Centinel Spine, LLC
West Chester, PA
01.2014 - Current
- Executive RAQA leader for a global spinal implant manufacturer registered in 30+ countries, including the United States, Canada, Brazil, Australia, and the European Union
- Serve as Management Representative and Person Responsible for Regulatory Compliance (PRRC).
- Authored and led regulatory strategy for 15+ PMA supplements, manufacturing supplements, and 30‑Day Notices, enabling sustained product evolution and uninterrupted commercialization.
- Directed cross-functional regulatory teams to perform EU MDR gap assessments, remediate and amend technical documentation, and successfully achieve MDR certification for Class III, Class IIa, and Class Ir medical devices.
- Designed, implemented, and maintained a global Quality Management System compliant with FDA, ISO 13485, EU MDR, and MDSAP, supporting multinational audits and market access.
- Led successful MDSAP readiness and ongoing compliance, integrating requirements for FDA, Health Canada, TGA, ANVISA, aligned processes.
- Directed regulatory submissions, international registrations, and manufacturing site onboarding to support rapid global expansion.
- Partnered with R&D, Marketing, Clinical, and Operations to ensure regulatory and quality alignment across design, labeling, advertising, and manufacturing changes.
- Led and hosted regulatory inspections and notified body audits; managed internal and supplier audit programs.
- Oversaw critical quality processes including complaints, adverse event reporting, field actions, design controls, risk management, CAPA, nonconformance, and change control.
- Provided strategic leadership to Quality Control teams responsible for raw material, in-process, and finished device testing, ensuring compliant product release.
- Provided strategic leadership to Supplier Quality teams supporting an outsourced manufacturing model, overseeing supplier qualification, performance monitoring, audits, and remediation to ensure compliance with FDA, ISO 13485, EU MDR, and MDSAP requirements.
- Built, mentored, and retained a high‑performing RAQA organization, fostering a strong quality culture across the enterprise.
Founder
Chestnut Ridge Quality Consultants
Downingtown, PA
01.2016 - Current
- Provide strategic RAQA consulting to small and mid-size medical device companies.
- Design and implement quality systems compliant with ISO 13485, ISO 9001, EU MDR, and FDA requirements.
- Conduct internal, supplier, and third-party audit support.
- Author regulatory submissions and technical documentation to support global registrations and approvals.
- Designed training programs enhancing staff competencies in quality assurance practices.
Manager, Quality Assurance & Regulatory Compliance
Stryker Orthobiologics
Malvern, PA
01.2012 - 01.2014
- Led QA/RA operations supporting a complex multi-sales-force commercial model.
- Partnered cross-functionally to maintain compliance with FDA, ISO, and internal Stryker standards.
- Reviewed and approved design, clinical, labeling, and manufacturing documentation.
- Supported multiple successful regulatory and notified body audits with zero findings across seven consecutive external audits.
- Integrated legacy quality systems into the Stryker quality framework.
- Managed and developed a team of quality engineers.
Progressive Quality Leadership Roles
Orthovita, Inc.
Malvern, PA
01.2005 - 01.2011
- Manager, Quality Control - Built and led a robust quality control laboratory supporting commercial and development programs. - Supported 10+ product launches and major manufacturing transfers. - Served as final signatory for batch record release. - Managed nonconformance, CAPA, calibration, and audit readiness. - Managed a $200K operating budget and over 1,000 calibrated assets.
- Supervisor / Analyst / Technician - Led microbiology, sterilization validations, environmental monitoring, and routine testing. - Served as lead internal auditor driving process improvement initiatives.
- Orthovita was acquired by Stryker Corporation for $318M.
Education
Bachelor of Science - Biology, Chemistry
Millersville University
Millersville, PASkills
- Regulatory Strategy
- PMA & Supplements
- Global Registrations
- MDSAP
- ISO 13485
- FDA 21 CFR 820
- EU MDR
- Design Controls
- Risk Management (ISO 14971)
- CAPA
- Audits & Inspections
- Complaint Handling & Vigilance
- Change Control
- Post-Market Surveillance
- People Leadership
Timeline
Founder
Chestnut Ridge Quality Consultants
01.2016 - Current
Senior Director, Quality & Regulatory Affairs
Centinel Spine, LLC
01.2014 - Current
Manager, Quality Assurance & Regulatory Compliance
Stryker Orthobiologics
01.2012 - 01.2014
Progressive Quality Leadership Roles
Orthovita, Inc.
01.2005 - 01.2011
Bachelor of Science - Biology, Chemistry
Millersville University
SELECT HIGHLIGHTS
- PMA Supplements: 15+
- Global Registrations: 30+ Countries
- Regulatory Audits: FDA, Notified Bodies, MDSAP Authorities
- Therapeutic Focus: Class III Implantable Medical Devices (Spine)