Sr. Regulatory Specialist

Job Description The Senior Regulatory Affairs Specialist is responsible for preparation of U.S. and CE marking submissions/registration activities, along with supporting all other geographical region registrations. In addition, this role will work cross-functionally to develop regulatory strategy across the product lifecycle. This role provides the flexibility to work on site 4 days weekly in Covington, GA, and remotely on Fridays. Key Responsibilities Lead regulatory strategy and lifecycle support for product project teams, including change controls, timelines, and submission document review. Prepare and maintain STED technical files to support CE marking and ensure compliance with EU MDR requirements, including notified body interactions. Provide regulatory guidance for post-market activities such as remediation actions and labeling updates. Lead and support U.S., EU, and international submissions, including NPD initiatives and change assessments. Drive process improvements, mentor team members, and support audits, regulatory inspections, and cross-functional initiatives (e.g., Kaizen events). Minimum Requirements Bachelor’s degree required, preferably in a scientific discipline or regulated industry; ability to travel up to 15% as needed. Experience authoring and supporting U.S. (510(k)), EU (Tech File/STED), and international regulatory submissions. Proven ability to update and maintain STED files for CE marking and support notified body interactions under EU MDR. Strong knowledge of U.S. and European medical device regulations, including familiarity with IEC 60601 standards and post-market regulatory requirements. Demonstrated ability to manage multiple projects, maintain strict confidentiality, and provide regulatory strategy, labeling review, and post-market guidance. Preferred Requirements 4-7 years experience in medical device, including product registration, new product development, and product changes. Regulatory Affairs Certification (RAC) preferred. Ability to provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, change control assessments, timeline development, and reviewing submission documents). Ability to work in a fast-paced, complex environment juggling various priorities. Self-motivated, capable of working independently and taking ownership of responsibilities. Technical writing skills and proficiency at compiling successful submissions for the appropriate audience. Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics. #J-18808-Ljbffr