Regulatory Affairs Specialist

Job Description

Job Description

Responsibilities :

• This position works closely with direct supervision to learn and develop the regulatory skills required to bring medical devices to market and ensure ongoing compliance
• This position is part of the Regulatory Affairs Compliance team, responsible to ensure local regulatory procedures adhere to government regulations, industry standards, and corporate policies; support internal and external audits; monitor regulatory systems for completeness and accuracy; and support other regulatory compliance activities, as needed
• Collaborates with Regulatory Affairs, Quality Assurance, and other associates on compliance support activities
• Understands fundamental global regulatory and quality system requirements
• Stays informed of new regulations and changes to existing regulations and communicates to management
• Monitors and analyzes regulatory information systems data; and coordinates actions to address issues
• Verifies product regulatory information to be submitted to global external databases
• Provides subject matter expertise on regulatory information systems to Regulatory Affairs team
• Provides regulatory support for internal and external quality system audits
• Supports development and implementation of corrective action plans for regulatory compliance findings
• Maintains FDA device listings and establishment registrations
• Writes and updates standard operating procedures (SOP), work instructions (WI), and policies and conducts internal training, as needed
• Conducts gap assessments of new and revised corporate procedures and external regulations and standards, and updates local documents accordingly
• Coordinates and responds to requests for product data and information
• Supports regulatory business processes
• Provides regulatory support for implementation of new systems and processes
• Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

Requirements :