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Job Information

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

Job Description Summary

Job Description

The Senior Regulatory Affairs Specialist is responsible for preparation of U.S and CE marking submissions/registration activities, with a primary focus on EU/MDR, along with supporting all other geographical regions registrations. In addition, this position will help support RA management with guidance and mentoring of department employees.

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

  • Regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, change control, timeline development, and reviewing submission related documents)

  • Prepare STED technical files for CE marking activities and notified body interaction to accomplish EU/MDR product remediation, as required

  • Provide support and guidance for post market activities including remedial actions, labeling and advertising and promotional material

  • Prepare and support 510(k), IDE, PMA and Design Dossier submissions as required

  • Provide the appropriate information to support International product registrations

  • May have direct supervisor responsibilities in addition to project team personnel; provides direction to assistant personnel QUALIFICATIONS:

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

  • Must be able to prioritize and handle several projects concurrently

  • Must be self-motivated by working independently and having the ability to take ownership of her/his responsibilities

  • Must be able to provide leadership and mentoring skills to less experienced regulatory personnel

  • Must have knowledge of the U.S. and European medical device regulations

  • Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience

EDUCATION and/or EXPERIENCE :

  • BS in a Scientific Field or Regulated Industry with 5-7 years experience in the areas of product registration, compliance or quality systems

  • Regulatory Affairs Certification (RAC) desired.

LANGUAGE SKILLS:

  • English

REASONING ABILITY:

  • Must demonstrate the ability to plan and complete regulatory pathway determinations, product registration submissions and other documentation

PHYSICAL DEMANDS:

  • Must be able to travel via airlines as needed

WORK ENVIRONMENT:

  • Traditional office environment

For many roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, weekly testing for COVID-19 may be available instead of vaccination. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to encouraging an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is crafted to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

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.

Primary Work Location

USA GA - Covington BMD

Additional Locations

Work Shift

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.

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

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