BD (Becton, Dickinson and Company) Regulatory Affairs Specialist I in Covington, Georgia

BD Urology and Critical Care is currently hiring Regulatory Affairs Specialist I. This position is a growth opportunity based in Covington, GA. Bard Medical has joined Becton-Dickinson together advancing the world of health.

This position is responsible for management of regulatory databases, provides product technical expertise, as well as assisting RA management in regulatory activities, including assessments, strategies and technical file maintenance.

  • Manage regulatory databases (UDI, products, technical files, etc.)

  • Research technical requirements for regulatory databases

  • Assist in technical interface between regulatory specialist and labeling specialist

  • Provide guidance on UDI labeling requirements as subject matter expert

  • Manage the technical file organizers in Master Control per guidelines

  • Assist in preparation of regulatory submissions (510(k)s, technical files, design dossiers)

  • Must be able to maintain confidentiality in dealing with regulatory and clinical documentation

  • Strong interpersonal skills in the areas of written and verbal communication

  • Must be able to prioritize and handle multiple projects concurrently

  • Must be self-motivated, work independently and have the ability to work with minimal supervision

  • Must be computer literate, proficient in Master Control, desired

  • Must be able to meet goals on time

  • Must have be able to research technical topics (product materials and attributes)

  • Must be computer literate, proficient in Master Control, desired

  • Must be a team player

  • BS/BA degree in a scientific discipline

  • One to Three years’ experience in medical device/FDA regulated industry

  • Regulatory Affairs Certification (RAC) desired

  • While performing the duties of this job, the employee is regularly required to sit, talk, and hear. The employee may occasionally lift objects up t 25lbs.

Traditional office environment. #LI-CW1

ID: 2018-11497

Career Level: experienced

Division Name: Bard Medical Division

Relocation Available?: No

External Company Name: C.R. Bard, Inc.

External Company URL: www.crbard.com

Street: 8195 Industrial Blvd.

C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.

We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.

Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.