Global Medical Safety Manager
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 Manager, based in San Clemente, California, will be responsible for overseeing processes related to complaint and Medical Device Reporting (MDR) / Vigilance system; to ensure compliance and confirm that established processes are followed. The Global Medical Safety Manager reviews reportability assessments and reports (i.e. MDRs, MDPRs, and Vigilance Reports); to ensure that all complaints are properly evaluated for U.S. and international MDR/Vigilance reporting.
MANAGEMENT OF COMPLAINT/MDR SYSTEM
· Oversees processes related to complaint and Medical Device Reporting (MDR) / Vigilance system to ensure compliance and confirm that established processes are followed
· Assists with standardizing process for assessing complaints for reportability
COMPLAINT INVESTIGATION/REPORTABILITY OF ADVERSE EVENTS
· Approves reportability assessments and decisions.
· Responsible for maintaining clinical follow-up questionnaires
· Ensures consistent decision rationales and risk assessment are documented in complaint files.
· Reviews complaint coding for accuracy
· Reviews and approves device evaluations completed by the quality assurance and engineering team
· Drafts and sends customer evaluation letters regarding complaint investigational findings.
· Oversees all aspects of the complaint investigation from opening to closure
· Reviews complaint records for accuracy and completeness
· Assists with generating trend reports on complaints and adverse events as needed
· Assists with regulatory report requests on complaints and adverse events as needed
· Assists with monitoring trends and making recommendations when PPRA or CAPA is warranted
· Assists with presenting trend reports at management review meetings as needed
· Assists with participation in PPRA and CAPA team meetings as needed
· Assists with development and standardization of complaint investigations
· Assists with reviewing standard operating procedures to ensure compliance with appropriate regulatory requirements
· Assists with training company employees on complaint/MDR regulations
· Assists with training employees/contractors on complaint and Medical Device Reporting (MDR) / Vigilance procedures.
· Minimum 5 years relevant work experience in clinical, pharmaceutical or medical device industry. At least 1 year of experience with complaints MDRs, and adverse event reporting. Ophthalmology experience preferable.
· Experience in Regulatory Affairs and/or Quality Assurance in medical devices, previous complaint handling experience strongly preferred
· Knowledge of regulation and standard affecting Medical Devices and Pharmaceuticals (i.e. ISO 9001/13485/14971, FDA Regulations (21CFR (803, 806, 820), JPAL, Medical Device Regulation (EU) 2017/745, Health Canada Medical Device Regulation, Australian Medical Device Incident Reporting & Investigation Scheme (IRIS), and Medical Device Single Audit Plan (MDSAP)).
· Ability to effectively communicate with customers and patients.
· Excellent written and verbal communication skills required due to frequent interaction with practicing ophthalmologists
· Ability to manage reporting timelines
· Ability to train employees on complaint and investigation requirements
· Able to generate and analyze trends and identify when corrective action is needed
· Excellent problem solving skills
· Self-motivated and able to work independently, as well as within a team
· Excellent organizational skills
· Experience with medical and ophthalmology terminology
Bachelor’s degree in nursing, or other health-related discipline and qualified to make a medical judgment (nurse, pharmacist, risk manager, or biomedical engineer).
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
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.