Senior Specialist – Regulatory Affairs

Senior Specialist – Regulatory Affairs

Requirements

• Minimum bachelor’s degree in RA, QA, engineering, or other science-related discipline
• Minimum of 5 years of strong Regulatory Affairs/Compliance experience in medical devices
• Knowledge of global Regulatory Affairs requirements, regulations, and standards
• Strong prioritizing, interpersonal, communication, and analytical skills, and the ability to multi-task disparate projects
• Excellent interpersonal, communication, and analytical skills and able to partner with cross-functional colleagues to identify regulatory innovation

Responsibilities

• Support regulatory effort to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR)
• Problem solve and escalate regulatory and compliance issues to senior management as necessary
• Drive continuous improvement in internal processes and customer satisfaction
• Support the monitoring and interpreting of current and new regulatory requirements and international standards for U.S. and RoW
• Support that QMS requirements are followed and executed consistently from RA perspective
• Support efforts for Technical File creation, remediation, and collaboration with cross-functional teams for required content
• Support regulatory impact assessments for change controls and other RA/QA items from a review and approve level
• Assist in preparing, auditing, editing, and publishing registration documentation as needed
• Support business export control (BEC) listing of product for release globally per RA requirements
• Support the review and approval of product labeling, promotional, and advertising materials as needed.

Preferred Qualifications

• Advanced degree (e.g. MS, Life Sciences) preferred
• RAPS RAC certification preferred