Staff Regulatory Affairs Specialist

Salary depends on experience
Posted on 11/22/17
Franklin Lakes, NJ
5 - 7 years experience
Medical Equipment
Salary depends on experience
Posted on 11/22/17

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

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