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Regulatory Affairs Specialist I

Apply Now Job ID R-345037 Date posted 08/09/2019

Job Description Summary

Job Description

The Regulatory Affairs Specialist I is responsible for implementation of regulatory strategies including domestic and international submissions and other support of product project team.

This position is a temporary assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy. This position will support Regulatory Affairs efforts and is anticipated to last approximately through June 30, 2022.

**This position does not offer relocation assistance**

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents)
  • Prepare and audit 510(k)s, IDEs, PMA and/or international submissions as required
  • Provide technical interface with FDA and international reviewers and respond to questions
  • Provide timely review and approval of product labeling and marketing claims for regulatory compliance
  • Provide support required for CE marking activities, including preparation and maintenance of product technical documentation files and clinical evaluations
  • May provide direction of other personnel to accomplish duties

QUALIFICATIONS:

  • Must have knowledge of the U.S. and European medical device regulations
  • Must have excellent written and verbal communication skills 
  • Must be self-motivated by working independently and having the ability to take ownership of her/his responsibilities
  • Must be able to prioritize and handle several projects concurrently
  • Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience
  • Must be able to provide leadership and mentoring skills to less experienced regulatory personnel
  • Must be able to maintain confidentiality in dealing with regulatory and clinical documentation
  • Must live within 50 miles of Covington, GA.

EDUCATION and/or EXPERIENCE:

  • BS in a scientific discipline with at least 2 years employment in the areas of regulatory product registration, compliance or quality systems; or
  • Combination of education and experience determined to be equivalent
  • Regulatory Affairs Certification (RAC) desired

Primary Work Location

USA GA - Covington BMD

Additional Locations

Work Shift

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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, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com