Medical Affairs Specialist

4 days ago

Concord, Massachusetts, United States Beta Bionics Full time
About Beta Bionics

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 Summary

We 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.
Requirements
  • 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.
Preferred Qualifications
  • 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.
Work Environment and Personal Protective Equipment

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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