Job Description: Summary
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
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.
Primary Work Location
USA GA - Covington BMD
BD (Becton, Dickinson And Company)