Complaint Handling Specialist

Beta Bionics, Inc. is a medical technology company dedicated to bringing innovative type 1 diabetes management solutions to the many, not the few. We are committed to bringing better access to better solutions – and a better life for those living with diabetes – with the world’s first bionic pancreas called the iLet. The iLet Bionic Pancreas is the first and only insulin delivery system that does not require carb counting*, bolusing, correction factors, or pre-set basal rates. The only number needed to get started with the iLet Bionic Pancreas is a user’s weight – the iLet does the rest. The iLet lets users “Go Bionic” with their diabetes management.
_{*User must be carb aware.}

Successful candidates will be working with highly experienced colleagues, who are amongst the best in their fields. We have a mission-driven, passionate and collaborative culture where you will have a high degree of empowerment and opportunity to make a significant impact.

Please contact us if you fit the profile below and if you are interested in joining the Beta Bionics team!


Position Summary:

We are seeking a detail-oriented Complaint Handling Specialist to join our Quality Assurance team. This role is responsible for supporting and managing medical device complaint activities, including intake, documentation, triage, investigation, regulatory assessment support, and timely closure of product complaints. The Complaint Handling Specialist will help ensure complaint files are accurate, complete, audit-ready, and compliant with applicable internal procedures, FDA Quality System requirements, ISO 13485, and other applicable regulatory expectations.

• →1-2+ years of experience in complaint handling, quality assurance, regulatory affairs, customer quality, or a related function in a regulated environment.
• →Strong documentation skills with the ability to write clear, accurate, and objective complaint records.
• →Excellent attention to detail, organization, time management, and follow-through.
• →Strong written and verbal communication skills, including the ability to work with cross-functional teams.
• →Ability to prioritize work and manage deadlines in a fast-paced, regulated environment.
• →Proficiency with Microsoft Office, including Excel, Word, and Outlook.

• Bachelor's degree in science, engineering, healthcare, or a related field, or equivalent combination of education and experience.
• Experience in the medical device, pharmaceutical, biotechnology, healthcare, or other FDA-regulated industry.
• Familiarity with FDA Quality System requirements, ISO 13485, MDR reporting, vigilance reporting, or other post-market surveillance requirements.
• Experience using a quality management system, complaint handling system, CRM, or other electronic case management platform.
• Experience reviewing product return evaluations, manufacturing documentation, device history records, or similar technical records.

• Regulatory documentation discipline and commitment to data integrity.
• Critical thinking and ability to assess incomplete or ambiguous complaint information.
• Sound judgment in identifying high-risk complaints and escalation needs.
• Ability to work independently while maintaining alignment with Quality, Regulatory, and operational procedures.
• Continuous improvement mindset and ability to identify recurring complaint themes or process gaps.
  

• While performing the duties of this job, the incumbent is regularly required to be independently mobile. The employee is also required to interact

$66,000 - $75,000

It is the policy of Beta Bionics to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Beta Bionics will provide reasonable accommodations for qualified individuals with disabilities.