Regulatory Affairs Specialist

Regulatory Affairs Specialist

Join us as a Regulatory Affairs Specialist at BD Nogales Norte. This role focuses on providing regulatory support for BD’s implantable and absorbable devices within the Interventional Surgery Business Unit. You will work under the mentorship of the Manager of Regulatory Affairs to manage changes to commercialized medical devices in the U.S. and international markets and to support the globalization of marketed products.

• Assess the necessity for reporting changes to FDA or Notified Bodies for proposed device modifications and prepare robust reporting justifications for changes that do not require supplements or notices.
• Identify and communicate appropriate 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.
• Maintain regulatory databases and systems for key regulatory data.
• Remain current on regulations affecting BD products and keep the relevant team and supervisors informed about potential product or process impacts.
• Provide regulatory support during internal and external audits and inspections.
• Support the 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.

• B.A. or B.S. degree in a technical field preferred (e.g., engineering, biology, chemistry, health science). A B.A. or B.S. in another field acceptable with appropriate level of experience.
• Minimum 1-2 years of 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 communication skills—analytical thinking and technical writing; ability to work on cross‑functional teams; ability to manage several parallel deliverables.
• 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.
• Working knowledge of U.S. medical device regulations, 21 CFR 820 Quality System Regulation and standards, FDA guidance documents, Good Clinical Practice standards, and Good Laboratory Practice regulations.

Primary

Work Location:

USA RI – Warwick

Fall River, MA $67,000.00–$95,000.00 3 weeks ago

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.