Bd-Ucc Business Unit Manager, Global Sterility Assurance

BD (Becton, Dickinson And Company) Covington , GA 30210

Posted 3 weeks ago

Job Description: Summary

Job Description

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

ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned.

  • 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 files and clinical evaluations

  • May supervise and direct Project Team personnel; may provide direction to assistant personnel

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

EDUCATION and/or EXPERIENCE:

  • BS in a scientific discipline with 3-5 years employment in the areas of medical device product registration (compliance or quality systems with Regulatory experience)

  • Combination of education and experience determined to be equivalent

  • Regulatory Affairs Certification (RAC) desired

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.

LI-PRO

Primary Work Location

USA GA - Covington BMD

Additional Locations

Work Shift

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Bd-Ucc Business Unit Manager, Global Sterility Assurance

BD (Becton, Dickinson And Company)