Sr. Regulatory Specialist

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 position 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, and remotely Friday on a weekly basis.

To be successful in this role, you will work independently by applying your written and analytical skills to create technical documents, in some cases covering design changes and change notifications for BD’s wide range of medical devices. You will also leverage your communication skills to work effectively with internal customers and team members as well as external auditors.

• 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).

• 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.

• 4 – 7 years experience in medical device (including experience within medical device); experience in product registration, new product development, and product changes highly preferred.
• Regulatory Affairs Certification (RAC) preferred.
• Demonstrated ability to provide regulatory support through the product lifecycle on product project teams (e.g., developing regulatory strategies, change control assessments, timeline development, and reviewing submission-related documents).
• Ability to work in a fast-paced and complex environment juggling various priorities.
• Self-motivated by working independently and having the ability to take ownership of responsibilities.
• Proficient technical writing skills and ability to compile successful submissions for the appropriate audience.

USA GA - Covington BMD

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.