Description
A global medical device company near Santa Barbara, CA is seeking a regulatory affairs director to join their team. A generous relocation package will be provided for an out-of-town candidate. The salary range for the position is $150,000-$200,000 with a strong equity component and long-term incentives.Job Summary
In short, the regulatory affairs director will mantain the regulatory compliance of business processes and will generate and revise product submissions to the FDA and international regulatory authorities. ESSENTIAL DUTIES AND RESPONSIBILITIESThe RA director generates and maintains Type II and IV master files with FDA. The RA director follows proper documentation procedures, including keeping accurate and current records. SUPERVISORY RESPONSIBILITIES Performs administrative functions relative to supervision of subordinates; the director of regulatory affairs will supervise a team of 8 but will also be very hands-on.
Qualifications
EDUCATION and/or EXPERIENCE
* Bachelor's degree from four-year college or university
* 5+ years of regulatory affairs experience
* 3+ years of management experience
* cGMP (medical device, pharmaceutical, excipient or combination product) experience* experience hosting on-site customer audits and performing vendor / subcontractor audits* experience hosting inspections by FDA and international regulatory authorities* Validation plan development and maintenance experience (process and test method)* Knowledge of master file CMC, CTD format for materials used in medical devices, APIs and combination products
Soft Skills
The regulatory affairs director should show relatively fast career progression with strong ambition and a passion to succeed and grow. The ideal candidate will have strong management skills and is knowledgeable and effective at working with the FDA; this person should speak to the standards but act for the business. It will be a hands-on position that will work cross-functionally and have the chance to wear many hats.