Regulatory Affairs Associate
US, US, CA - San Diego
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: No travel required
Location: CA - San Diego
Performs the coordination and preparation of document packages for regulatory submissions for new and mature products for domestic and international markets.
- Execute regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards.
- Prepare or assist in the preparation of international submissions for medical devices. Maintain proficiency on regulatory requirements.
- Under the direction of the department manager, manage the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products manufactured and/or distributed by third-party distributors.
- Work with cross-functional team members to successfully execute strategy for new product development projects.
- Instill and drive a regulatory culture
- Provide continuing support of on-market product and associated manufacturing process changes by assessing their impact on product registrations/licenses, communicating the impact to the organization and gaining approval for those changes
- Review labeling, advertising, and promotional materials to assure confirmation with international labeling requirements
- Must be cooperative and work well with all functional groups
- Responsible for communicating business related issues or opportunities to the next management level
- Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485
- Previous experience with orthopedic devices
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, 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, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company's portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With more than $1 billion in revenues, NuVasive has approximately 2,600 employees and operates in more than 50 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.