Pear Therapeutics is the leader in prescription digital therapeutics or PDTs. Pear aims to redefine medicine by discovering, developing, and delivering clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from the FDA. Pear’s lead product, reSET®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of opioid use disorder, was the first PDT to receive Breakthrough Designation. Pear’s third product, Somryst™, for the treatment of chronic insomnia, was the first PDT submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program. For more information, visit Pear at www.peartherapeutics.com.
Pear Post Market Surveillance Analyst work closely with patient services, handle and review customer feedback, triage complaints and maintain complaint records. As part of that team, you will learn with us, helping us navigate the line between lean, agile, and regulation to build safe and effective treatments. This position is based in San Francisco and we are open to remote candidates
A Typical Week at Pear:
- Interface with the Pear Patient Service Center to collect and categorize customer feedback and complaints, and improve the product feedback and vigilance processes
- Review Customer feedback and complaints and perform and document root cause investigations
- Lead investigations into potential software defects and bugs, coordinating between the Product, Data Science, Design and Software Engineering teams
- Write risk assessments, bug reports and other health hazard evaluations as needed
- Collect and transfer product improvement opportunities to the product teams
- Support the Design Quality engineers in developing software documentation supporting post-market design changes, change assessments
Things we consider critical to be a successful Post Market Surveillance Analyst at Pear:
- You can self-manage a consistent routine and schedule
- You are detail oriented and dedicated to producing quality outputs
- You have strong communication skills and are passionate about supporting processes that facilitate clarity.
- You are comfortable and enjoy working with the latest software tools including Slack, Trello, and related project management software
- Others enjoy working with you because of your technical competence and ability to work well in a team
- You care that the work you do has a positive effect on other humans.
- Expertise in medical device Quality Management System regulations and standards including ISO 13485 and 21 CFR 820 (knowledge of 21 CFR 210/211 desirable)
- Excellent computer skills, familiarity with electronic Complaint Management Systems and Quality Management Systems
- Bachelor of Science degree in Engineering or Computer Science required or equivalent industry experience with medical software
- Familiarity with medical and clinical terminology
- 5+ years as a Complaint Analyst, Quality Engineer, Software Quality Assurance, or other quality function.
- Experience with stand-alone Software as a Medical Device