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Regulatory Affairs (Medical Device)

Technical/Functional Skills:

The Regulatory Affairs Specialist should provide direct Worldwide Regulatory support to various projects and products. Candidate should support strategic planning and product development efforts, and provide Regulatory support for existing products with respect to product changes/modifications, labeling, and promotional material review and approval.

• Knowledge of Medical Device Regulatory, FDA regulations, CE and ISO, etc,
• Excellent communication skills, both verbal and written.
• Good organizational skills.
• Good analytical thinking, problem-solving, and investigative skills
• Required Experience 1 to 3 years.

Roles & Responsibilities:

• Writes, coordinates, and completes the submission of Regulatory documents to the FDA and other Regulatory agencies (e.g., EPA). Includes international documents (e.g.,
• tech files, etc.)
• Prepares responses to FDA questions and other Regulatory correspondence
• Provides direct Regulatory support to project teams including the creation of detailed Regulatory Plans
• Includes in-depth team involvement including Core Team membership
• Conducts product labeling and advertising review and approvals
• Evaluates proposed product modifications for Regulatory impact. Completes Regulatory Assessments as needed
• Good experience in medical device quality control.
• Subject Matter Expert on medical device-specific regulatory affairs.
• Other activities as assigned including special projects, as needed
• Perform other work-related duties as assigned by the manager of the role
• 510(k)s and determinations as to whether a device modification may trigger the need for a new one.
• Manage an internal team of resources working on different regulatory-related client projects.
• Liaison between client Program engagement manager and Hops Healthcare delivery execution team for assigned projects.