REGULATORY AFFAIRS SPECIALIST Second Sight Medical Products
THIS JOB HAS EXPIRED POSITION SUMMARY: The position is responsible for diverse regulatory functions, including but not
exclusive to the development of Medical Device submissions and the implementation of Regulatory
ESSENTIAL DUTIES AND RESPONSIBILITIES:
? Assist in preparation of submissions for US and OUS regulatory agencies to gain approval to
conduct clinical trials and to gain approval to market company?s products.
? Perform country-specific product registrations and license renewals
? Maintain regulatory files (i.e., product catalog, submissions, vigilance and MDR reports, and
? Maintain current knowledge of the developments and changes to applicable laws, regulations and
? Provide support function for federal (US) and notified body inspections of company?s operations.
? Prepare and update product labeling that meets regulatory requirements.
? Perform labeling verification activities including preparation of specifications, protocols and
? Interact and interface with regulatory agencies as necessary.
? Provide support in maintaining customer complaint handling system
? Prepare and update departmental / standard operating procedures
? Provide assistance in product notification and recall activities.
? Work with cross functional teams to ensure proper coordination of information to meet regulatory
EDUCATION/CERTIFICATION: BS degree required, preferably in Engineering, Physical or Biological
sciences. Regulatory Affairs Certification (RAC) or equivalent required
EXPERIENCE REQUIRED: Minimum 3 years of experience in US regulatory affairs, preferably with
Class III devices, or equivalent combination of education and experience.
? Knowledge of US / OUS medical device regulations, such as FDA QSR, FDA
IDE/HDE/PMA regulations, and the European Active Implantable Medical Device Directive.
? Understanding of FDA compliance and GCPs.
? Excellent people skills, team oriented
? Effective written and verbal communication skills
? Detail-oriented with strong organizational skills
? Strong computer skills (word processing and database programs)
||12744 San Fernando Road |
Sylmar, CA 91342
THIS JOB HAS EXPIRED