
Specialist, Regulatory Affairs
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.
Understanding of regulatory requirements throughout the product lifecycle
5+ years of related experience in the medical device industry
Able to evaluate the regulatory impact of proposed product and process changes
Time Management Skills
Analytical skills (data driven)
Technical design and documentation skills
Compliance Reporting
Verbal communication
written communication
Problem Solving Skills
Flexibility/Adaptability
Detail Oriented and Organized
multitasker
According to JobzMall, the average salary range for a Specialist, Regulatory Affairs in 7475 Lusk Blvd, San Diego, CA 92121, USA is between $98,000 and $115,000. This range is based on the salary data of similar positions in the same area. The salary range may vary depending on the experience and qualifications of the individual.
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We believe in advancing the global adoption of less invasive surgery to help patients around the globe suffering from back pain. Through the integration of industry-leading procedures and enabling technologies, we advance the standard of care to help hundreds of thousands of patients each year. Our commitment is to deliver the safest, most efficient technology in the OR to help improve clinical and economic outcomes.

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