Lead Quality and Regulatory Engineer

San Mateo, California, United States Full-time

Evidation Health is a new kind of health and measurement company that provides the technology and guidance to understand how everyday behavior and health interact. The volumes of behavior data generated from wearables and smartphones has opened up new ways to analyze individuals’ behavior and health in real time. With a virtual pool of 2 million research participants, Evidation Health undertakes research for innovative biopharma and health care companies to transform how diseases are identified, treated, and monitored. 

Evidation Health’s Lead Quality and Regulatory Engineer will be charged with supporting operational excellence of Evidation’s quality management system in order to deliver 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, and project management. Ability and willingness to multi-task is a must. This is a full-time role based in San Mateo, CA.

RESPONSIBILITIES

  • Review quality management procedures and update / revise as necessary
  • Develop training materials and deliver training to educate cross-functional team on regulations / guidelines, such as Good Clinical Practice and Quality Management System
  • Spearhead implementation of processes and procedures to support development of software in compliance with IEC 62304 and IEC 62366
  • Develop process and templates to translate study protocol into requirements and test plans; Spearhead roll out to cross-functional teams
  • Lead Design Control and Risk Management activities related key projects and support study validation activities prior to study launch
  • Own relationships with outside vendors and research partners related to key projects such as diagnostic testing labs including evaluating vendors, adding to Approved Supplier list, working with vendor to outline logistics related to specific study requirements and monitoring supplier performance.
  • Manage QMS training requirements and documentation
  • Assist in drafting and reviewing regulatory submissions for medical devices (SaMD) and development tools
  • Work with cross functional team to monitor, document, investigate and report complaints and adverse events related to studies
  • Work with cross-functional teams to develop processes and procedures for technology deployments to sites including procurement and inventory management  
  • Train internal trainers or site-based trainers in study technology

QUALIFICATIONS

  • Self-motivated and takes initiative
  • Undergraduate university engineering degree required
  • 5+ years of work experience required
  • Experience in the quality management systems including software life cycle management and human factors required
  • Experience with regulatory submissions preferred
  • Familiarity with HIPAA, human subjects research, and good clinical practices and clinical research experience preferred
  • Demonstrated exceptional project management skills
  • Proven ability to develop technical product expertise and effectively collaborate with product/engineering teams
  • Efficient multi-tasker able to juggle multiple projects in various phases simultaneously
  • Must be self-motivated, fast-paced, team-oriented, extremely organized
  • Excellent written and oral communication skills
  • Proficient in: Google docs and sheets; Microsoft Word, Excel, and PowerPoint
  • Comfortable with ambiguity and eager to partner both internally and externally to build creative solutions

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
  • Your choice of computing equipment and gear
  • Lots of opportunities for growth
  • Opportunity to work on fascinating challenges that improve people’s lives
Evidation Health values diversity and is committed to equal opportunity for all persons without regard to race, color, creed, religion, marital status, age, national origin or ancestry, political activity or affiliation, physical or mental disability, medical condition including genetic characteristics, marital status, sexual orientation, gender identity, sex or gender.

Apply for this opening at http://evidation.recruiterbox.com/jobs/fk01x33?apply=true