Post Market Surveillance AnalystAugust 30, 2021 2021-09-03 19:08
Website PEAR THERAPEUTICS
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.
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.
- 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
- 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
- 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.