Post Market Surveillance Analyst Job at Stryker Corporation – in Cork
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Post Market Surveillance Analyst to join our Neurovascular Division to be based in Fremont, CA.
Who we want
Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
What you will do
As a Post Market Surveillance Analyst, you will enter customer complaints into the company-wide complaint system and follows methods to analyze the complaints for the Neurovascular business.
Responsibilities may include but are not limited to:
Review and determine reportability of complaints to FDA and international regulatory authorities.
Write, review, and file Medical Device Reports (MDRs) and international Vigilance Reports.
Works closely with Sales Representatives and health care professionals to obtain additional information.
Monitor quality, completeness and timeliness of complaint investigations.
Write customer response letters.
Contribute to achieving team performance metrics and goals.
Represent Quality function as a member on team projects to complete assignments or delegate assignments.
Collaborate with other Neurovascular teams, customers, and regulatory agency representatives, to develop product solutions.
Review team progress with management.
What you need
A Bachelor’s Degree in a technical or scientific discipline required.
A minimum 1 years of experience as a Regulatory or Quality professional in a regulated manufacturing environment, preferably Medical Devices.
Experience with FDA Medical Device Reporting preferred.
Knowledge/certification on medical device regulations and guidelines preferred.
Experience with MDR/MDV reporting preferred.
Applied knowledge of US and International Medical Device Regulations and Standards including but not limited to: FDA: CFR 21 Part 803 (MDR), and CFR 21 Part 820 (QSR), MEDDEV 2.12-1 (Guidelines on Medical Device Vigilance System), ISO 13485 (International Organization for Standardization) preferred.
Proficient in Microsoft Office Suite, including Word, Excel and PowerPoint.
Excellent organizational, problem-solving, and analytical and time management skills.
Ability to interface with both technical and non-technical personnel at all organizational levels.
Demonstrated problem-solving and troubleshooting skills.
Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines.
Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.
Know someone at Stryker?
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Company: Stryker Corporation –
Company Location: Cork