NuVasive, Inc. Sr. Regulatory Affairs Specialist in San Diego, California

Sr. Regulatory Affairs Specialist

US, US, CA - San Diego

Minimum Level of Education Required:Bachelors Degree

Percentage of Travel:Up to 10%

Location:CA - San Diego

Ref#:16935

Job Description

As a Senior Regulatory Affairs Specialist at NuVasive, you are responsible for preparation and maintenance of both U.S. and foreign regulatory pre-market submissions and other premarket filings to acquire appropriate commercial distribution clearances in an expeditious manner. 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 regulatory impact of 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 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.

  • Must be detail oriented & highly organized.

  • Must demonstrate teamwork building skills in & outside department.

  • Ability to exercise judgment

  • Ability to prioritize workload with limited direction

Basic Qualifications

  • Bachelor's degree

  • 5+ years of related experience, specifically in the medical device industry authoring medical device 510(k) pre-market notifications

  • In depth understanding of Regulatory Affairs as it applies throughout the product lifecycle

  • Strong understanding of pre-market submission types and requirements

  • Understands regulatory terminology

  • Strong knowledge of US FDA Quality System Requirements (QSR), and ISO 13485.

  • In depth knowledge of labeling requirements per 21 CFR Part 801, 820, and ISO 13485, and EU Medical Device Directive

  • 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.

Preferred Qualifications

  • Experience with orthopedic industry and project development.

  • Strong knowledge of various international regulations such as EU MDD.

  • Regulatory Affairs Certification (RAC).

  • Experience with electrical medical devices and associated IEC requirements

  • Experience with reprocessing (cleaning and sterilization) of medical devices

  • Experience with SharePoint and SAP are desired in order to perform assigned responsibilities.

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 at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally invasive, 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 $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

©2015 NuVasive®, Inc. Privacy at http://www.nuvasive.com/privacy-policy/ Terms and Conditions at http://www.nuvasive.com/terms-conditions/

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 at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .

Nuvasive is committed to working with and providing reasonable accommodation to individuals with disabilities. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at careers@nuvasive.com.