Sr. Regulatory Affairs Specialist

Description

The Regulatory Affairs Senior Specialist is responsible for product remediation projects, process and systems remediation projects, and the preparation of regulatory submissions required to legally market medical devices in the European Union under the MDR. This role will provide support for global product registrations and related regulatory affairs activities.

Responsibilities

• Supports product remediation projects and process/systems remediation projects
• Prepares regulatory submissions required to legally market medical devices in the European Union under the MDR
• Provides support for global product registrations and related regulatory affairs activities
• Applies relevant regulations and statutes to further product submissions of basic to medium complexity
• Translates technical data and descriptions into reviewer-friendly content
• Interacts with regulatory bodies to help further product approvals or clearance
• Executes project activities based on applicable products and systems to ensure adherence to regulatory requirements
• Manages change and provides solutions flexibly while working independently with minimal guidance
• Determines own work priorities and collaborates with regulatory team and cross-functional team members to build strong and effective working relationships
• Acts as a resource for colleagues with less experience

Requirements

• Demonstrable in-depth knowledge of preparing a submission, applying relevant regulations and statutes to further product submissions of basic to medium complexity, and translating technical data and descriptions into reviewer-friendly content
• Ability to interact with regulatory bodies to help further product approvals or clearance
• Experience managing change and being flexible when providing solutions
• Ability to work independently with minimal guidance while determining own work priorities
• Experience managing projects based on applicable products and systems to ensure adherence to regulatory requirements

Qualifications

• Bachelor’s degree or advanced degree in a technical area such as biology, chemistry, engineering or medical-related field
• 4+ years employment in Regulatory Affairs, areas of product registration, compliance, or quality systems