Sr. Regulatory Affairs Specialist – International

Sr. Regulatory Affairs Specialist – International

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 – International

The Sr. Regulatory Affairs Specialist - International is responsible for managing OUS 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

In partnership with Marketing, R&D, Quality, and Clinical Affairs:

• Submit regulatory submissions for OUS markets.

• Work in partnership with Clinical Affairs to prepare clinical summary data for regulatory submissions of new products as well as maintain current clinical evaluation reports.

• Provide input and guidance to R&D regarding OUS regulatory requirements for new and existing products.

• Serves as the liaison between company and OUS government, non-governmental agencies and partners to achieve product clearances.

• 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.

• Manage regulatory annual reporting of products and product changes.

• Provide regulatory assessment for changes to commercially released products.

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

• Work with Quality regarding UDI registrations.

• Review marketing materials to align with OUS 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.

  • 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. Communicates 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 within the diabetes space.

• Detailed knowledge of US and global regulations including QSRs, ISO 13485, Japan, Europe, Brazil, etc.

• Hands-on experience with OUS submissions and related requirements.

• Excellent technical writing skills and analytical abilities.

• Knowledge of R&D design controls.

• 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.

• Strong team building/leadership skills.

• Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other employees.

• Ability to work in a highly detailed environment where mental focus and accuracy of work output is essential.

• Good organizational and communication skills, including ability to represent the company to both internal and external audiences.


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.