Job Description Summary

The Staff Regulatory Compliance Specialist is responsible for working with all sites worldwide on various regulatory compliance issues, with primary focus on the BD Interventional Segment. The individual in this position will develop, implement, and/or coordinate global regulatory programs and projects and compliance initiatives across regions, business units, and manufacturing sites. This position reports directly to the Sr. Manager, Regulatory Compliance.

Job Description

Duties and responsibilities for this Regulatory Compliance role include:

• Field action activities including but not limited to participation at situation analysis meetings, documenting regulatory rationales for “no action taken”, agency reporting, customer letter development, communication with all regions, and monitoring of trends.
• Input to the Compliance Profile Report, as well as Management Review.
• Monitoring Adverse event reporting as well as the processes and procedures
• Acts as an official correspondent with FDA and notified bodies on all related matters as appropriate.
• Participates in the development, review and issuance of BD policies and procedures related to regulatory compliance.
• Supports implementation and maintenance of UDI
• Provides training for compliance and/or quality system activities as required
• This position may have no direct reports, however must accomplish tasks through coaching and cooperation with other Regulatory, Quality, Medical, Operations, and R&D professionals worldwide.

Qualifications:

• BA or BS degree, with 5-7 years related experience in the medical device or pharmaceutical industry.
• Working knowledge of 21 CFR820, ISO 13485, ISO 14971 and other international standards as required
• Proficiency in Microsoft Office, specifically Word and Excel
• Must be able to work effectively across BD units, regions, and manufacturing sites
• Excellent written and oral communication skills
• Strong Organization & Prioritization Skills
• Certifications in Regulatory Affairs/Compliance desirable

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Primary Work Location

USA MD - Baltimore

Additional Locations

USA GA - Covington BMD

Work Shift