Senior Specialist, Regulatory Affairs
US, US, CA - San Diego
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 10%
Location: CA - San Diego
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
- 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.
- 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.
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