Regulatory Affairs Specialist

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Location :
San Diego, California

Expiry Date :
Tue, 06 Apr 2021 23:59:59 GMT

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Description :
Regulatory Affairs Specialist US, US, CA – San Diego Minimum Level of Education Required: Bachelors Degree Percentage of Travel: No travel required Location: CA – San Diego Ref#: Job Summary and Primary ResponsibilitiesAs a Regulatory Affairs Specialist at NuVasive, you are responsible for assisting with product submissions globally, with a focus on products containing software. 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. – Ability to determine and communicate submission and approval requirements to others – Control and maintain regulatory records. – Represent Regulatory Affairs on various design and development teams by attending team meetings and providing the required plans, procedures, and regulatory decisions. – Confer with other departments about the regulatory requirements of new product designs and/or changes to existing designs. – 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. – 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. – Perform other duties as assigned Required Skills / Capabilities – Understanding of regulatory terminology, pre-market submission types, and requirements – Basic understanding of regulatory requirements throughout the product lifecycle – 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 – Must be detail-oriented & highly organized. – Must demonstrate team-building skills in & outside the department. – Ability to exercise judgment – Ability to prioritize workload with limited direction – Proactively assembles necessary information and establishes informal working networks within the company to solve departmental challenges. – Understands requirements of project plans and focuses activities on meeting plan objectives. Education and Experience – Typically requires a Bachelor’s degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience – 2+ years of related experience, specifically in the medical device industry with a focus on software devices and mechanical electrical equipment preferred 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 NuVasiveNuVasive, 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 .