Medical Affairs Specialist
4 days ago
Beta Bionics is a pioneering medical technology company dedicated to revolutionizing type 1 diabetes management. Our mission is to bring innovative solutions to the many, not the few, and to make a meaningful impact on the lives of those living with diabetes.
Job SummaryWe are seeking a highly skilled Medical Affairs Manager to join our team. As a key member of our commercial operations team, you will play a critical role in supporting the sales, marketing, and customer care teams in their efforts to bring our innovative diabetes management solutions to healthcare providers and patients.
Key Responsibilities- Develop and implement training programs, labeling, and marketing materials to support the commercial launch of our devices and algorithms.
- Collaborate with regulatory teams to ensure compliance with FDA regulations and submissions related to new and existing devices and algorithm changes.
- Provide clinical guidance and advice to various departments within the company to ensure that new products or modifications to existing products meet medical needs, regulatory, and safety requirements.
- Serve as a resource for questions related to off-label or non-traditional use of our devices, 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 reviewing device-related complaints and providing clinical guidance on reportability and causality of events when possible.
- Bachelor of Science degree in a relevant field.
- 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 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 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.
- Master's Degree in a relevant field.
- Certified in diabetes care and education (CDCES or BC-ADM).
- Experience in medical device industry and medical affairs.
This job is considered a hybrid of remote and on-site work, operating in a professional environment. The 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.
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.
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