Clinical & Regulatory Manager

San Mateo, California, United States Full-time

Evidation Health’s Manager of Clinical & Regulatory will be charged with ownership of operational excellence of Evidation’s quality management system in order to support high quality health outcome studies. This role requires a broad range of skills, including, but not limited to, cross-functional communications (internal and external), analysis, problem solving, project scoping, and project management. Ability and willingness to multi-task is a must.

What you'll do

  • Ensure study projects maintain compliance to quality mgmt system requirements and manage design history files (DHF) for Evidation products.
  • Identify and assess potential suppliers that may provide study product and/or services for health studies; Develop and execute supplier specific project plans and manage timelines to ensure study product availability.
  • Serve as face of cross-functional team to supplier and ensure supplier maintains compliance to the quality requirements and contractual obligations.
  • Manage approved supplier list (including consultants and clinical service providers); In addition, manage contracts with suppliers and clinical sites to support study start-up activities; Coordinate resource staffing at facilities and/or clinical sites as needed.
  • Manage external audits (including quality system and the privacy/security system); Ensure action plans are appropriately implemented to close out reports on-time.
  • Regulatory guidelines / Industry standards – Develop expert knowledge in related FDA and industry standards on Software and digital/mobile app development

What you bring

  • Demonstrated exceptional project management skills
  • Experience in the quality management systems
  • Knowledge of and experience with technology deployments 
  • Must be self-motivated, fast-paced, team-oriented, extremely organized
  • Excellent written and oral communication skills
  • Comfortable with ambiguity and eager to partner both internally and externally to build creative solutions

 Who we are

  • Mission driven and passionate about making things that matter in healthcare
  • Hard-working, but also respectful of personal time
  • Dedicated to creating stable systems that automatically scale to meet demand 

Benefits

  • Health, dental, and vision benefits for you and competitive coverage for your family
  • Relocation support
  • Equity
  • Flexible work hours
  • Open vacation policy - take time when you need it
  • Support for remote work when needed
  • Relaxed work environment
  • Choice of computing equipment and gear
  • Lots of opportunities for growth
  • Work on fascinating challenges that improve people’s lives

Apply for this opening at http://evidation.recruiterbox.com/jobs/fk0fjaf?apply=true