Staff Regulatory Affairs Specialist

Becton Dickinson and   •  

Franklin Lakes, NJ

Industry: Medical Equipment

  •  

5 - 7 years

Posted 424 days ago

This job is no longer available.

Job Description Summary

This position will beresponsible for all aspects of regulatory affairs including development and execution of global regulatory strategies and submissions formedical devices and drug/device combination products. The incumbent will perform essential duties andresponsibilities with minimal supervision while providing guidance to more junior regulatoryassociates.

Job Description

  • Manage customers' submission requirements to understand their Regulatory requirements in order to liaison with a cross functional team to address customer requirements
  • Responsible for all B2B regulatory requests and submission
  • Develop a regulatory process supporting the B2B Platform
  • Represent the Regulatory Affairs function at the global cross functional business or product platform level.
  • Analyze and interpret current or proposed domestic and international regulations for impact to BD products and processes to help ensure continuous compliance.
  • Develop and execute global regulatory strategies by collaborating closely with cross-functional product development teams and regulatory associates around the world.
  • Assess the impact of device modifications and develop robust non-filing justifications for US/EU regulated products.
  • Coordinate and prepare premarket applications to the US FDA such as pre-submission meetings, 510(k)s, de Novo, IDE, or PMAs.
  • Coordinate and prepare submissions to European Notified Bodies for timely approval of new products and product changes
  • Provide support to regional regulatory associates for timely approval of BD products worldwide.
  • Review and approve product labeling and promotional materials for compliance to global regulatory requirements.
  • Participate in relevant trade organizations and regulatory standards development as necessary to support BD’s continuous product development and compliance efforts.

Education:

B.S. degree or higher in a technical discipline, preferably in computer science, engineering, bioengineering, biology, or chemistry

Experience:

  • At least 5 years of experience with medical device regulations is required
  • At least 2 years of experience with devices containing software or  drug-device combination products is preferred.
  • Human factors and usability engineeringexperience is preferred.
  • Understanding of regulatory frameworks, and the ability to interpret and apply new or emerging regulations.

Skills:

  • Strong organizational and written/verbal communication
  • Attention to detail
  • Demonstrated problem solving abilities
  • Self-motivated with the ability to effectively manage and prioritize multiple complex tasks.

Job ID R-18129