Website PEAR THERAPEUTICS

About Pear

Pear Therapeutics is the leader in prescription digital therapeutics. We aim 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 severe psychiatric and neurological conditions. Our first product, reSET®, treats Substance Use Disorder and was the first prescription digital therapeutic to receive marketing authorization from the FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of Opioid Use Disorder, received marketing clearance from the FDA in December 2018. Pear’s third PDT, Somryst®, is the first FDA-authorized prescription digital therapeutic (PDT) for patients with chronic insomnia and the first product submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program.

Description:

We’re looking for a product Complaint Analyst looking to contribute to a fast-paced software medical device company. As part of the Post-Market team in the Quality Assurance department, you will be reviewing and handling customer feedback, triaging complaints, maintaining complaint records, and working closely with our Patient Services group.

Responsibilities:

  • Review Customer feedback and complaints, and maintain complaint records in compliance with Pear procedures and medical device regulations
  • Perform root cause investigations and risk assessments, and coordinate other health hazard evaluations as needed
  • Document potential software defects and bugs, coordinating with Product, Data Science, Design and Software Engineering teams
  • Collect and transfer product improvement opportunities to the product teams
  • Interface with Pear Patient Services team to collect and categorize customer feedback and improve the product feedback and vigilance processes
  • Support the Design Quality engineers in developing software documentation supporting product nonconformances and post-market design changes

Required Skill/Competencies:

  • Ability to self-manage, detail oriented, and dedicated to producing quality outputs
  • Comfortable using electronic Quality Management Systems and excellent computer skills, including Google and Microsoft Office tools
  • Expertise in medical device Quality Management System regulations and standards including ISO 13485, ISO 14971 and 21 CFR 820 (knowledge of 21 CFR 210/211 desirable
  • Familiarity with medical and clinical terminology
  • Others enjoy working with you because of your technical competence and ability to work well in a team
  • Preferred: Experience with stand-alone Software as a Medical Device (SaMD)
  • Nice-to-Have: Familiarity with SQL programming language

Education/Experience:

  • Bachelor’s degree (engineering or technical discipline desirable) or equivalent industry experience
  • 1+ years as a Complaint Analyst, Quality Engineer, or similar quality function
  • 1+ years experience working in medical device industry or similar regulated industry preferred

To apply for this job please visit peartherapeutics.com.

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