Global Medical Safety Specialist
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.
The Global Medical Safety Specialist, based in San Clemente, California will be responsible for receiving, documenting, evaluating, and coordinating investigations of customer complaints associated with Glaukos Corporation products in accordance with federal and international regulations. The Global Medical Safety Specialist will be responsible for tracking and trending customer complaints and reporting on those results and will work with other departments on known and emerging issues to resolve quality issues. The role will also be responsible for maintaining awareness of new products and all applicable government rules, regulations, and published guidance.
- Design, execute, monitor, and manage complaint databases and files for all customer complaints in accordance with 21 CFR Part 803 Medical Device Reporting and other international regulations.
- Review and evaluate all possible complaints received by Glaukos to identify whether a Glaukos customer complaint has been made and determine whether an investigation is required.
- Assist Medical Safety Manager/ Sr. Manager to maintain Glaukos complaint handling procedures and systems and make updates as necessary to ensure ongoing compliance with U.S. and international regulations.
- Coordinate with Customer Service, Regulatory, and Quality, to gather root cause determinations and properly document complaint closure.
- Coordinate with Medical Safety Manager/Sr. Manager to ensure that all complaints are properly evaluated for U.S. and international adverse event reporting.
- Evaluate documentation for completeness and consistency, resolve issues with missing information, and assign additional actions as necessary to close complaints in a timely manner.
Standard Operating Procedures/Other:
- Maintain awareness of new products and all applicable government rules, regulations, and published guidance.
- Provide ancillary support in representing the complaint handling process during internal and external audits.
- Compile, maintain, and analyze post market data for discussion and assist with the implementation of any resulting corrections or corrective actions.
- All other duties and tasks as required and requested by management.
Education and Experience:
- A Bachelor's degree in an engineering or clinical field, or an equivalent combination of relevant experience and education.
- Experience in Regulatory Affairs and/or Quality Assurance in medical devices, previous complaint handling experience strongly preferred
Knowledge, Skills and Abilities:
- Adaptable and flexible in a fast moving industry
- Strong communication and organizational skills required
- Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities
- Expertise in Microsoft Office applications and charting programs.
- Must be detail-oriented.
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture: https://www.themuse.com/companies/glaukoscorporation
Glaukos has been recognized by the Orange County Business Journal as one of the best companies to work for in in Orange County, check out page 8 at http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf
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