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

Job ID: 2018-11792

Career Level: experienced

Relocation: No

Location: Covington,Georgia,United States


BD Urology and Critical Care is currently hiring Regulatory Affairs Associate. This position is a growth opportunity based in Covington, GA. Formerly Bard Medical, we have joined Becton-Dickinson a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care.

Summary of Position with General Responsibilities:

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.

Essential job Functions:

  • 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)

Basic Qualifications:

  • 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)

Additional Desirable Qualifications Skills and Knowledge:

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

  • Must be a team player

  • Must live 50 miles in distance from facilty in Covington GA

Education and/or Experience:

  • BS/BA preferred

  • Five years’ experience in medical device/FDA regulated industry

  • Regulatory Affairs Certification (RAC) desired

Physical Demands:

  • 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.

Work Environment:

Traditional office environment. #LI-CW1

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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