Senior Specialist - Regulatory Affairs

October 2

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Medical Devices • Biosciences • Medical Supplies • Laboratory Instruments • Reagents

10,000+

Description

• Support regulatory effort to comply with new and existing regulations • 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.

Requirements

• Minimum bachelor’s degree in RA, QA, engineering, or other science-related discipline • Advanced degree (e.g. MS, Life Sciences) preferred • RAPS RAC certification preferred • 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

Benefits

• Competitive salary • Opportunities for personal development • Supportive work culture