Founded in 1982, STAAR Surgical Company develops, manufactures and globally distributes medical
devices for use in cataract, refractive and glaucoma surgery. The Company's product lines
include silicone and Collamer� foldable intraocular lenses, Sonic WAVE� phacoemulsification
system,the ICL (implantable contact lens) for the treatment of near- and far-sightedness and
the AquaFlow� Collagen Glaucoma Drainage Device. Regulatory approvals vary by market.

STAAR Surgical is regarded as a technology leader in the industry. As STAAR continues to grow,
creativity remains an important tool in technology, marketing and in building new financial
strength. The company is headquartered in Monrovia, California, and has operations in various
countries around the world.

MAIN JOB RESPONSIBILITIES/FUNCTIONS


� Responsible for receiving, reviewing, monitoring and trending of product complaints for STAAR
Companies
� Supervise the Corporate Complaint department associates
� Organizes and oversees all communications received relevant to the investigation and
resolution of all product complaints
� Provides training and guidance to Corporate Complaint department associates
� Provide cross-functional support and training to Sales/Marketing, customer service, returned
goods personnel, and QA associates and engineers involved in complaint investigations and
complaint reporting
� Establishes or oversees contact with healthcare professionals submitting product complaints
which may have caused or contributed to patient safety issues. Evaluates information to
determine if the event falls within the classification of Medical Device Reportable event and
Vigilance Reporting under the EU Medical Device Directive, Canadian Medical Device regulations
and other International reporting requirements.
� Prepares and submits Medical Device Reports (MDR) to the U.S. Food and Drug Administration
under the Medical Device Reporting Statues/Regulations
� Prepares Medical Device Vigilance System submissions under the EC Medical Device Directive
� Prepares and submits Medical Device Reports under Canadian Medical Device regulations
� Requests complaint failure investigations be performed by the appropriate facility
� Oversees the evaluation of returned products
� Prepares and distributes written correspondence to customers
� Establishes and track key quality indicators to measure effectiveness of the complaint system
and compliance with goals, ISO requirements, and FDA regulations
� Conducts trend analysis of complaint information and prepares periodic reports as required
� Writes departmental Standard Operating Procedures
� Attends training and education seminars as appropriate to keep current with international and
domestic regulatory requirements for complaint handling
� Keeps informed about current regulatory initiatives through the review of regulatory
publications
� Conducts audits of complaint files
� Performs other duties as directed by management

EDUCATION & QUALIFICATIONS:

Bachelor degree or advanced degree in science or other technical field or equivalent experience
in a device or pharmaceutical company

EXPERIENCE:

� A minimum of 5 years experience in complaint handling in accordance with FDA Medical Device
Reporting (MDR), Medical Device Vigilance (MDV) reporting, Canadian Medical Device reporting,
and other international reporting requirements
� Knowledge in US, Canadian and European/International regulations and standards
� Previous supervisory experience

Skills:

� Possesses excellent interpersonal skills
� Has excellent written, verbal, analytical, organizational and computer skills with attention
to detail

Contact Information 
 
 
Company: STAAR Surgical Company 
Email: [email protected]