Regulatory Affairs Specialist

Becton Dickinson Medical Devices•Warwick, RI

11d•Onsite

About The Position

We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. This position will be working in the BD Interventional Surgery Business Unit on implantable and absorbable devices. Under the mentorship of the Manager of Regulatory Affairs, the position will provide technical and administrative regulatory support required to assess changes to commercialized medical devices in the U.S. and international markets. Additionally, the position will provide regulatory support to expand the globalization of marketed products.

Requirements

B.A. or B.S. degree in a technical field preferred (e.g., engineering, biology, chemistry, health science).
B.A. or B.S. in other field acceptable with appropriate level of experience.
Minimum 1-2 years Regulatory Affairs experience in medical device or in vitro diagnostic device companies.
Proven ability to resolve problems and to make appropriate regulatory decisions.
Good oral and written communications skills - analytical thinking and technical writing; ability to work on cross-functional teams; ability to manage several parallel deliverables.
Working knowledge of US medical device regulations, 21 CFR 820 Quality System Regulation, and standards, FDA guidance documents, Good Clinical Practice standards, Good Laboratory Practice regulations.

Nice To Haves

Proficient in using Microsoft Word, Excel, PowerPoint, and Project.
Strong communication and project management skills.
Must be able to handle multiple tasks with attention to detail with limited supervision.
Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork skills.

Responsibilities

Assess necessity for reporting changes to FDA/Notified Body for proposed device modifications.
Prepare robust reporting justifications for changes that do not require supplements or notices.
Sends out notifications of change to Notified Body as required.
Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies to stakeholders.
Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
Maintains regulatory databases/systems for key regulatory data.
Remains current on regulations affecting BD products and keep the relevant team and supervisors informed about potential product or process impacts.
Provides regulatory support during internal/external audits and inspections.
Support development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register devices worldwide.
Review and approve product labeling, promotional, and advertising materials to ensure regulatory compliance.
Carry out the above tasks with minimal supervision.