Regulatory Affairs Specialist I: MedTech Submissions

Regulatory Jobs; Covington (GA); On-site; USD 70,000 - 90,000; Full time

Job summary

BD, a leading global medical technology company, is seeking a Regulatory Affairs Specialist I for the UCC urinary healthcare initiatives in Covington, GA. You will implement regulatory strategies and support domestic and international submissions across product lifecycles.

Responsibilities include developing regulatory strategies, preparing 510(k)s, IDEs, PMAs, international submissions, reviewing labeling for compliance, and coordinating CE marking activities.

Qualifications

• BS in a scientific field with 1+ years in medical device registration or quality systems
• RAC certification desired
• Knowledge of US and European medical device regulations
• Excellent written and verbal communication skills

Responsibilities

• Provide regulatory support through the product life cycle on product project teams
• Prepare and audit 510(k)s, IDEs, PMA and/or international submissions
• Provide technical collaboration with FDA and international reviewers and respond to questions
• Provide timely review and approval of product labeling and marketing claims for regulatory compliance
• Support CE marking activities, including preparation and maintenance of product technical files and clinical evaluations

Skills

Regulatory affairs knowledge

FDA submissions

Cross-functional collaboration

Technical writing

Communications skills

Education

Bachelor's degree in a scientific field

Job description

BD, a leading global medical technology company, is seeking a Regulatory Affairs Specialist I for the UCC urinary healthcare initiatives in Covington, GA. You will implement regulatory strategies and support domestic and international submissions across product lifecycles.

Responsibilities include developing regulatory strategies, preparing 510(k)s, IDEs, PMAs, international submissions, reviewing labeling for compliance, and coordinating CE marking activities.