Job Description

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.

Summary/Objective:

The Medical Affairs Manager will work within established company objectives and finances to support the sales/marketing/customer care teams as healthcare providers and patients use the device commercially. The Medical Affairs Manager will also support the engineering, R&D, quality, shipping, and regulatory departments by providing clinical guidance related to the use of the device commercially.

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]

Support Commercial Clinical Operations:

• Support the development of all training, labeling and marketing materials (internal, commercial, etc.) in collaboration with marketing, sales teams and customer care to support clinics, patients, and providers using the device, including throughout changes to the insulin-only algorithm and device, at launch of the bihormonal product, and beyond
• Work with the regulatory team to support all FDA correspondence and submissions related to new and existing devices and algorithm changes
• Provide clinical guidance and advice to all departments within the company to ensure that new products or modifications to existing products meet medical needs of users and healthcare providers, as well as regulatory and safety requirements
• Serve as a resource for questions related to off-label or non-traditional use of the iLet, including answering inquiries from the field clinical team or healthcare providers, representing Beta Bionics at conferences and events, and presenting to healthcare providers as needed
• Support the Quality, Complaint Handling, and Failure Investigations department in review of device-related complaints and provide clinical guidance on reportability and causality of events when possible

Other Duties and Responsibilities

• Participate in third party and internal quality audits involving areas of responsibility. Assist with related corrective/preventive action planning and implementation
• Establish and maintain Standard Operating Procedures and Forms related to areas of responsibility to comply with US and International (as applicable) Good Clinical Practice regulations and pertinent standards, including US 21CFR50, 54, 56 and 812 and ISO 14155
• Other duties as assigned by Supervisor
• Comply with privacy expectations/HIPAA and other regulatory, legal, and safety requirements
• Provide support and guidance to fellow Clinical Operations Associates as needed
• Operate with high standards that are aligned to certified B-Corp values
• Consider the beneficiaries of Beta Bionics' Public Benefit Mission Statement with all actions and decisions

Required Education and Experience

• Bachelor of Science degree
• Clinical licensure (RN, RD, NP, PA, RPh)
• Five or more years of clinical experience in the diabetes space
• Ability to transfer clinical insights into product design, training, and market acceptance
• Competence in drafting clinical documents including guidelines, support and troubleshooting, and journal articles
• Ability to work with within a regulated device process with daily communication with departments such as Quality, Regulatory, Sales, Clinical, Marketing and Customer Care
• Excellent attention to detail, organizational skills, and flexibility to handle multiple tasks and the pressure of deadlines
• Ability to utilize scientific/technical information to ensure documents produced are consistently accurate and complete
• Self-motivated, takes ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary
• Proficient in pertinent software and tools including Microsoft Office suite, Adobe Acrobat, and Salesforce.
• Ability to communicate professionally in verbal and written format with physicians, researchers, and patients
• Knowledge of medical device industry clinical requirements, relevant US regulations, and guidance including ICH GCP guidelines
• Strong team building/leadership skills

Preferred Experience and Qualifications

• Master's Degree
• Certified in diabetes care and education (CDCES or BC-ADM)
• Experience in medical device industry and medical affairs

Work Environment and Personal Protective Equipment

• This job is considered a hybrid of remote and on-site work, operating in a professional environment. Candidate will be expected to work with the rest of the department in the Concord office 1-2x/week at a minimum. Occasional travel will be required. This job routinely requires the use of standard office equipment such as computers, phones, copiers, 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.
• This position requires travel up to 20% depending upon business needs.

Salary Range

$115,000 - $145,000

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.

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