Regulatory Affairs Specialist

Prepare U.S. FDA and Health Canada submissions for new products and product changes to ensure timely approval for market release. Lead submission activities for devices in gaining required clearances through the processes of IDE’s, 510(k) s, PMA’s, CE marking. Lead and provide regulatory planning and execution guidance to senior engineering and marketing personnel. Conduct post-market surveillance such as literature reviews, clinical study reviews, etc. Maintain the company’s Medical Device Listing and Device Establishment registration forms. Maintain regulatory affairs product files to support compliance with requirements.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Madrona, Torrance, CA, USA is $47,000 - $91,000. This range is an average of salaries reported by several job postings on the site. The salary range may vary depending on the experience level of the individual and the company.

Engineering Recruitment Designed by Engineers for Engineers. 180 Engineering does not try to be all things to all people. Rather, we are a boutique, service-intensive talent acquisition firm specializing in matching engineering and information technology (IT) talent talent with career opportunities. 75% of the jobs we fill range from executive to junior levels within the product development and manufacturing lifecycle.