Volcano Corporation is dedicated to developing breakthrough technologies that save people's lives and enhance their current quality of life! At Volcano you will find a pioneering and innovative spirit with a wide range of opportunities.
Without the exceptional professionals at Volcano Corporation, we simply could not fulfill our mission to improve the lives of patients worldwide.
Provide regulatory support to the Regulatory Affairs Department ensuring compliance with applicable US and international regulations in which the company does business; preparing product submission documentation, evaluating design changes for affects on regulatory filings, and providing guidance to project teams as it relates to application of regulatory requirements. RESPONSIBILITIES:
Prepare and maintain regulatory submissions, including US 510 (k)'s, IDE's, EU Technical File/Design Dossiers, and other international documentation as required.
Participate in and provide required deliverables to development teams as the internal regulatory team member and FDA liaison throughout the product development cycle, submission, pre-approval, launch and post marketing phases for assigned projects.
Conduct regulatory assessments, review, and approve manufacturing and design changes as appropriate.
Review and approve promotional material as required.
As necessary, performs other duties as required.
Qualifications:
EDUCATION:
BA/BS in a scientific discipline or equivalent work experience.
Regulatory Affairs Certified (RAC) preferred.
KNOWLEDGE AND EXPERIENCE:
A minimum of three to five (3-5) years of experience in Regulatory Affairs.
Demonstrated successful submission experience
Previous experience working with development teams providing guidance on regulatory requirements.
Demonstrated Regulatory compliance knowledge.
SKILLS AND ABILITIES:
Knowledge of FDA and international regulations
Well-developed organizational skills required
Advanced written and verbal communication skills
Previous practical experience in regulatory activities in cardiovascular medical device applications highly desirable
Detail oriented and thorough
Good analytical skills
Ability to work independently and have good time management skills
Proficiency in Microsoft Office Suite, particularly Word and Excel.
PROBLEM SOLVING AND DECISION MAKING:
Determining the significance of various product and process specifications and changes and determining required regulatory documentation.
Knowing where to locate needed information to solve questions or clarifications
Deciding most appropriate methods for executing assigned tasks.
PHYSICAL DEMANDS:
Must be able to sit for prolonged periods of time
Must be able to lift 10 lbs
Headquartered in San Diego, CA, Volcano maintains expansive facilities housing engineering, laboratory, manufacturing, and production operations in Northern California, Costa Rica, and various locations worldwide. Volcano is an Equal Opportunity Employer. It is the policy of Volcano Corporation, to base all employment decisions on the principles of equal employment opportunity and to take affirmative action in the employment of women, minorities, individuals with disabilities, and veterans.
