About Beta Bionics

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.

Beta Bionics is a public benefit corporation. This means we are a for-profit company with obligations to serve both our public benefit mission and shareholders' interests. Beta Bionics is also a certified B Corporation; and as such accountable to operate with high standards of transparency, sustainability and accountability to our customers, employees, business partners, society, and the environment.

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!

*User must be carb aware.

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Summary/Objective:

The Complaint Specialist works with a team of Quality, Clinical and Regulatory Affairs professionals to provide hands-on complaints handling and ensure customer complaints are reviewed and processed in a timely manner. Duties include, but are not limited to, day to day complaint review, investigation, adverse event reporting and complaints trending.

Essential Duties and Responsibilities

[Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Qualified candidates who need a reasonable accommodation with the application process and/or to perform the essential functions of the position should notify the company's HR contact]

• Receives, reviews, documents, evaluates, investigates, and coordinates responses on product complaints.
• Evaluates complaints and completes complaint Medical Device Reporting (MDR) decision trees.
• Performs device history reviews for complaint investigations and gathering of additional information, working closely with other departments to complete investigation reports.
• Evaluates all information from a regulatory and technical perspective to ensure appropriate analysis and investigation.
• Interacts with the complaint investigation team regarding event information and investigation report status.
• Participates in investigations and corrective action arising from customer complaints.
• Reviews daily processes to ensure issues are being addressed and escalated in a timely manner.
• Ensures timely completion of complaint closures, including completion of investigations and communicates with supervisor and team members to ensure appropriate actions are taken.
• Analyzes customer complaints trends and identifies potential corrective or preventive actions.
• Maintains current and complete complaint files and ensures complaint files and records are in compliance with regulatory requirements.
• Identifies and implements efficiency and compliance improvements to the complaint management process.

General Duties

• Participates in internal and external quality audits involving areas of responsibility as required.

• Establishes, maintains Standard Operating Procedures and Work Instructions related to areas of responsibility.

• Advises other Company personnel concerning areas of responsibility within the complaints process

• Communicates information related to quality management system reviews.

• Works in accordance with quality system procedures.

• Other duties as assigned by Supervisor.

• Operates with high standards that are aligned to Certified B-Corp values.

• Consider the beneficiaries of Beta Bionics' Public Benefit Mission with all actions and decisions.

Required Education and Experience

• Associate or higher degree in a scientific or engineering discipline, mechanical, electrical or software engineering preferred.
• 2+ years practical experience in medical device complaint handling process.
• Knowledge in FDA 21 CFR 820 and 21 CFR 803.
• Experience working in a medical device industry.
• Strong communication and organization skills required.
• Accuracy, attention to detail, and thoroughness.
• Proficiency required with Microsoft applications.

Preferred Experience and Qualifications

• Working experience in diabetes care including infusion pump or CGM therapies a plus.
• Prior experience with a web-based or electronic complaint system.
• Experience submitting Medical Device Reports.
• Demonstrated problem-solving , critical thinking, and investigative skills working relationships.
• Proficient knowledge of medical terms and human anatomy.
• Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing.
• Ability to manage confidential information with discretion.
• Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other employees and supervisor.
• Ability to work in a highly detailed environment where mental focus and accuracy of work output is essential.

Work Environment and Personal Protective Equipment

• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopier, and scanners.

Physical Demands

• While performing the duties of this job, the incumbent is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with co-workers.

Salary Range

$26.50 - $31 per hour

Benefits

• Comprehensive medical and dental coverage
• FSA and HSA Plan Options, including an annual company contribution to the HSA
• 401(k) program with employer match
• Generous vacation accrual and paid holiday schedule

Equal Employment Opportunity Statement

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.