Regulatory Affairs Specialist II
Job Description Summary
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.
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
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
Must have command of the English language
Should have mathematical skills commensurate with educational background and necessary for describing and summarizing laboratory and/or clinical data in product registration submissions
Must demonstrate the ability to plan and complete regulatory pathway determinations, product registration submissions and other documentation
Must be able to operate computer and office equipment as needed
Must be able to travel via airlines as needed
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 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 LocationUSA GA - Covington BMD
Recommanderà un ami
Approbationdu Présiden et Chef de la direction
«Nous sommes une entreprise qui vise des résultats concrets et où nos associés s’emploient chaque jour à améliorer les soins de santé. De nombreuses initiatives sont en cours pour faire de BD un leader mondial des technologies médicales.»
Anonyme, Franklin Lakes, NJ