Job Description Summary
The Staff Regulatory Compliance Specialist is responsible for working with all Preanalytical Systems (PAS) sites worldwide on various regulatory compliance issues. 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 Manager, Regulatory Compliance.
Duties and responsibilities for this Regulatory Compliance role include:
- Field action execution for the PAS business, 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, coordination with 3rd party recall contractor, responding to customer questions on field actions and monitoring of trends.
- Input to PAS 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.
- Supports Quality Systems with Regulatory inspections
- Facilitates documentation of segment or corporate audit program for PAS sites
- Works in coordination with Regulatory Affairs to maintain establishment registrations for all PAS facilities.
- Participates in the development, review and issuance of BD PAS policies and procedures related to regulatory compliance.
- Supports implementation and maintenance of PAS Unique Device Identification (UDI).
- Provides training for compliance and/or quality system activities as required.
- This position may have no direct reports; however, this individual must accomplish tasks through close cross-functional cooperation with other BD Regulatory, Quality, Medical, Operations, and R&D professionals worldwide.
- 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
- 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