Regulatory Affairs (RA) Manager

Key Responsibilities:

• Provide regulatory guidance for medical devices and drug/device combination products throughout the entire product lifecycle.
• Review and manage documentation related to the device lifecycle.
• Ensure compliance with local regulatory authorities and applicable regulations.
• Lead device labeling activities.
• Manage and implement post-marketing changes.
• Drive regulatory projects and develop strategies for post-market modifications.
• Serve as the regulatory point of contact for specific device vendors.
• Oversee the preparation and submission of device-specific regulatory chapters.

Education & Experience:

• Bachelor’s degree in Engineering or equivalent.
• Minimum of 8 years of experience in Regulatory Affairs within medical device development and manufacturing.

Skills & Abilities:

• Extensive post-market regulatory experience.
• Proficiency in Quality System Regulations (QSRs), ISO 13485, MDD/MDR, MDSAP, and FDA standards.
• Knowledge of software regulatory affairs (preferred).
• Strong decision-making and effective communication skills, including reporting to senior management.
• Proven ability to work independently.
• Understanding of configuration management and document control principles.

Reporting Line:

• Reports to the Senior Director of Device Regulatory Affairs.