Saumil Mehta Email and Phone Number

• Established product regulatory compliance requirements based on product marketing specifications for new high-volume product development projects• Developed & executed compliance plans to enable time-critical high-priority/high-revenue country certifications• In support of team initiatives, spearheaded efforts to transition & streamline compliance management processes and tools to a consolidated over-arching end-to-end cloud-based solution

• Successfully executed multiple regulatory compliance change management projects to mitigate business risks arising from changing regulatory requirements• Implemented new requirements and associated process workflows to mitigate potential data security and privacy risks in compliance management applications• As a Business Continuity Program Lead, developed & implemented business continuity plans, conducted business impact assessments and implemented gap resolution in the recovery processes• As part of the organization’s operational efficiency initiative, lead project to optimize and digitize legacy processes & governance workflows with dashboarding of key operational metrics• In partnership with Supply Chain & IT, developed & deployed cloud-based solution with operational metrics dashboards to proactively monitor & resolve compliance gaps to mitigate operational risks• Conducted internal compliance lab audits which enabled identification of process gaps and drive effective closures to mitigate compliance risks• Assumed the role of Operational Lead for the development and adoption of the ‘As a Service’ business model for regulatory compliance programs.• As a Designated Team Lead for the compliance program, improved operational efficiencies through structured process adherence and establishing skills parity• Guided cross-functional team leads to develop & implement processes to enable continuous compliance and self-governance

• Planned & conducted over 100 ISO internal audits (onsite & virtual) including overseeing effective resolution of non-conformances and remediation plans• Executed Supply Chain on-site third-party supplier audits and gap assessments across North America to identify and enable effective mitigation of potential business-impacting risks• Collaborated with third-party service providers that ensured successful execution of Statement of Work (SOW) and maintained high service standards; established & implemented operational metrics for effective governance• Conducted regular reviews of corporate program policies and process documents that maintained accuracy and conformity with ISO documentation standards• Mentored and guided cross-functional teams by delivering training programs that increased policy awareness and compliance through self-governance• As a Program Manager for Global Corporate Lab Programs spearheaded efforts that resolved systemic gaps in corporate lab policies and processes compliance; established compliance metrics and reporting for senior leadership and cross-functional stakeholders

• Lead a team of 10 Manufacturing Engineers and Analysts supporting multiple high-volume product lines for new product development, handoff to contract manufacturing for production; enabled consistent design for manufacturability & quality (DFM, DFQ) implementation• Spearheaded New Product Introduction (NPI) process and application enhancement efforts resulting in streamlining the product development and release cycles. Seamlessly incorporated change-management processes for new component and process qualifications.• Development new technology roadmap that enabled effective implementation of Design for Manufacturability (DFM) criteria in the product development lifecycle• Instrumental in coaching & mentoring teams to develop cross‐functional knowledge & skills