Senior Regulatory Affairs Specialist

As a Senior Regulatory Affairs Specialist at NuVasive, you are responsible for leading product submissions globally, with a focus on products containing software. This is a remote position, but we are preferring candidates in the San Diego, CA area. Each day offers exciting new challenges as you tackle a variety of tasks including:

• Determine/document appropriate regulatory strategy for proposed new products and initiate necessary activities by working with Regulatory management as needed.
• Evaluate the regulatory impact of the proposed product and/or process changes, and determine if a new pre-market application is required
• Ability to lead & organize project meetings and coordination of tasks to obtain required deliverables
• Confer with other departments about the regulatory requirements of new product designs and/or changes to existing designs
• Responsible for assisting Engineering in the maintenance of Design History Files and related records on an as-needed basis, and where regulatory responsibilities permit
• Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry
• Demonstrates global regulatory expertise in product submissions and ability to evaluate changes with local regulations
• Ability to determine, communicate and make recommendations for submission and approval requirements to others
• Represent Regulatory Affairs on various design and development teams by being a main point of contact, attending team meetings and providing the required plans, procedures, and regulatory decisions
• Perform other duties as assigned
• Control and maintain regulatory records

• Ability to exercise judgment
• Understands requirements of project plans and focuses activities on meeting plan objectives.
• Must be detail-oriented & highly organized.
• Basic understanding of regulatory requirements throughout the product lifecycle
• Must demonstrate team-building skills in & outside the department.
• Knowledge of US FDA Quality System Requirements (QSR), and ISO 13485.
• Knowledge of labeling requirements per 21 CFR Part 801, 820, and ISO 13485, and EU Medical Device Directive and EU Medical Device Regulation
• Proactively assembles necessary information and establishes informal working networks within the company to solve departmental challenges.
• Understanding of regulatory terminology, pre-market submission types, and requirements
• Ability to prioritize workload with limited direction

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Salary Range: $96,000.00 - $160,000.00

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For roles that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The Company's less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. The Company's comprehensive procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. With more than $1 billion in net sales, NuVasive has approximately 2,700 employees and operates in more than 50 countries serving surgeons, hospitals, and patients. For more information, please visit www.nuvasive.com.