Regulatory Affairs Specialist II

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Job description

Job Description Summary

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

SUMMARY:

The Regulatory Affairs Specialist II is responsible for implementation of 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 product registration, compliance or quality systems; or
• Combination of education and experience determined to be equivalent
• Regulatory Affairs Certification (RAC) desired

LANGUAGE SKILLS:

• Must have command of the English language

MATHEMATICAL SKILLS:

• Should have mathematical skills commensurate with educational background and necessary for describing and summarizing laboratory and/or clinical data in product registration submissions

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 operate computer and office equipment as needed
• Must be able to travel via airlines as needed

WORK ENVIRONMENT:

• Traditional office environment

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 fostering 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 designed to support the varying needs of our diverse and global associates.

To learn more about BD visit

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