Rob Schulz Email & Phone Number

Los Angeles, CA, US

Westlake Village, California, US

Upon acquisition by ToxStrategies as a Divisional Sr. VP, provides technical and organizational leadership for Suttons Creek. Leads team of 20+ technical and ops team members who support pharma clients from startups to global 100 leading pharma companies. Operationalizes strategic vision, with responsibilities that include organizational development and.

Westlake Village, California, US

Led Suttons Creek to a year over year revenue growth of 50% annually and quadrupled the size of the organization, leading to the acquisition by ToxStrategies. Responsible for oversight of all aspects of strategy and operations for Suttons Creek including sales, marketing, accounting, legal, human resources, and technical operations. Ensure that strategy is.

Westlake Village, California, US

Responsible for oversight of the entire Suttons Creek technical staff and consulting network for execution of all deliverables. Implemented systems and offerings to drive continuous growth. Provided executive oversight of key programs and engaged with clients to ensure alignment and quality of work output. Responsible for a network of 50+ global.

Westlake Village, California, US

Head of Regulatory Systems (Regulatory Affairs and Quality Systems) and Lead Client Regulatory Consultant providing regulatory strategy, submissions support, quality systems implementation and remediation for the development of combination products for pharmaceutical and medical device clients.

Waltham, MA, US

Responsible for Regulatory Affairs, Risk Management, and Post Market Surveillance for Class II IVD’s, Software, and Companion Diagnostics. Division lead for IVDR remediation and RA lead for legal manufacturer and physical manufacturing site move.

Thousand Oaks, CA, US

Device Regulatory Lead for multiple drug entities. Successfully led multiple regulatory approvals for novel devices and combination products including electromechanical and devices in the digital health space.

Valencia, CA, US

Global Head of Regulatory and Quality reporting directly to the CEO for Class I and II devices, including Class II sterile implantables. Managed the quality and regulatory functions for US, Israel, and EU location.

Dublin, Coolock, IE

With a primary focus on international regulatory affairs, led the successful global approval of multiple Class II and III device submission. Managed the Costa Rica regulatory team and change management activities. Process owner of the global regulatory process.

Marlborough, MA, US

External standards subject matter expert. Familiar with PMA, FCC, and IDE submissions. Knowledge of complaint handling/reporting.

Marlborough, MA, US

Managed 6 Field Clinical Engineers that supported currently marketed devices and post market clincial studies in North America. Employees were regionally based across the United States. Created a formal traning program, attended and assisted in neurostimulator implants and follow ups, completed technical study data, and acted as a liason between field.

St. Paul, Minnesota, US

Managed a group of 8 engineers who provided phone and sustaining engineering support for cardiac pacemakers, ICD's, and the associated accessories. Established and managed the Remote Device Monitoring Team that supported direct upload of patient data and supported patients during this process.

Bs, Biological Sciences

Ms In Progress, Regulatory Science