Sr. Regulatory Affairs Specialist

Sr. Regulatory Affairs Specialist

About Beta Bionics

Beta Bionics, Inc. is a medical technology company working to commercialize the world’s first bionic pancreas called the iLet®. The iLet bionic pancreas is a wearable investigational device designed to autonomously control glucose in people with diabetes or other conditions of glycemic dysregulation.


Fueled by investments from high-profile funds and strategic partners and leveraging technology backed by years of clinical data, we are now entering a tremendously exciting phase in our development as we prepare to begin our large pivotal clinical trial and anticipated commercialization of the iLet bionic pancreas.


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 and dedicated to bringing to market our truly disruptive technology. 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 us on this journey to achieve Beta Bionics’ bold commitment to the millions of people waiting for the iLet bionic pancreas!


Sr. Regulatory Affairs Specialist

The Senior Regulatory Affairs Specialist is responsible for executing Regulatory Affairs activities.


Location and Travel

This position is based in Concord, MA. This position is expected to travel within the United States up to 10% of the time.


Key Job Responsibilities

• Work with RA and other functional areas to write regulatory submissions as needed.

• Work with Quality and R&D to provide regulatory input on complaint resolution and submit Medical Device Reports and Vigilance Reports.

• Submit regulatory annual reporting of products and provide regulatory assessment for changes to investigational and commercially released product.

• Manage device listings, registrations, licenses and distribution authorizations for worldwide markets.

• Regulatory oversight and review of distributor agreements.

• Provide regulatory support for FDA inspections, including BIMO audits, as well as notified body audits.

• Collaborate with Quality regarding due diligence and annual audits of critical partners such as distributors and clinical research and coordinating organizations.

• Work with Quality regarding UDI registrations.

• Review CAPAs, HHEs for regulatory requirements.

• Stay updated on US and OUS regulatory requirements.

• General 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.

  • Advise and train other Company personnel concerning areas of responsibility.

  • Ensure appropriate communication processes are established within and across functional groups.

  • Communicate information related to quality management system effectiveness.

• Other duties as assigned by Supervisor.


Required Education and Experiences

• Bachelor’s Degree in a scientific discipline or equivalent experience required. Regulatory Affairs Certification preferred.

• 2-5 years of Regulatory Affairs experience in medical devices, preferably with a background in working with Complaints, MDRs and Vigilance Reporting.

• Detailed knowledge of US and global regulations including QSRs, e-MDR, and ISO 13485.

• Excellent technical writing skills and analytical abilities.

• Ability to influence all stakeholders involved to execute on deliverables.

• 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 office software and tools such as Microsoft Suite (Excel, Powerpoint, Word, etc.) and Adobe Pro, etc.

• Ability to communicate professionally in verbal and written format with regulators, physicians, researchers and patients.

• 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.

• Good organizational and communication skills.


Benefits

• Training and mentorship with ongoing learning and development courses

• Comprehensive medical and dental coverage

• 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.


How to Apply

If you are interested in the position, please submit your resume to HR@betabionics.com.


Authorization to work in the United States is a precondition to employment in this position. Beta Bionics will not sponsor candidates for work visas for this position.

CAUTION: The iLet® bionic pancreas is an investigational device limited by Federal (or United States) law to investigational use. Not available for sale.

© 2021 Beta Bionics, Inc. Beta Bionics® and iLet® are registered trademarks of Beta Bionics, Inc. All rights reserved. All other trademarks are the property of their respective owners. The use of third-party trademarks does not constitute an endorsement or imply a relationship or other affiliation.