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Senior Specialist, Regulatory Affairs

  • Anywhere

Company :
NuVasive

Location :
San Diego, California

Expiry Date :
Mon, 26 Apr 2021 23:59:59 GMT

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Description :
Job Summary and Primary Responsibilities Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements. Compiles all materials required in submissions, license renewal, and annual registrations. Recommends changes for labeling, manufacturing, marketing, and the clinical protocol for regulatory compliance. Monitors and improves tracking and control systems. Keeps abreast of regulatory procedures and changes. Recommends strategies for the earliest possible approvals of clinical trial applications. – Determines the appropriate regulatory strategy for new products and documents all related activates to remain in compliance – Collaborates with various departments to review the required plans, procedures, and regulatory decisions for new or existing products – Reviews regulatory requirements from other departments for new product designs or changes to existing designs – Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry – Prepares and maintains regulatory pre-market submissions and other pre-market filings to assist in acquiring appropriate commercial distribution clearances – Supports product import by providing applicable regulatory documentation and certificates – Performs other duties as assigned Required Skills / Capabilities – Understanding of regulatory requirements throughout the product lifecycle – Solid understanding of regulatory terminology, pre-market submission types, and requirements – Able to evaluate the regulatory impact of proposed product and process changes – Capable multi-tasking skills with the ability to project plan and meet deadlines – Result-driven with a sense of responsibility, urgency, and ability to perform under pressure Education and Experience – Typically requires a minimum of 5 years of related experience with a Bachelors degree; or 3 years and a Masters degree; or a Ph.D. without experience; or equivalent work experience – 5+ years of related experience in the medical device industry NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, or protected veteran status and will not be discriminated against on the basis of disability. The EEO is the Law poster options are available here. NuVasive’s EEO policy is available here. About NuVasive 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 .