Product Surveillance Specialist

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better. 

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing, and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future. 

Objectives: 

Primary responsibility is to support the global reporting obligations and the management of communication between manufacturer, distributors and competent authorities for all medical device complaint related activities, including assistance of and/or submission of medical device event reports in accordance with applicable local laws and regulations.

Responsibilities:

• Provide understanding, leading analysis and management of information regarding medical device complaint events and/or adverse events, follow-up, case processing and assessment for post-marketing activities.
• Receives, documents and evaluates complaint information.
• As required, communicates with physician, physician's staff and/or patient to obtain pertinent complaint information.
• Evaluates and engages appropriate management for critical and/or unusual events.
• Liaises with internal functions (Quality, Regulatory, Medical Affairs, Customer Service, Manufacturing and R&D) to gather critical input into medical device event reports.
• Reviews complaint manufacturing investigation reports and provides comments in accordance with procedures.
• Ensures complaints are processed in a timely manner.
• Reviews and closes complaint files.
• Compiles case and process metrics.
• Performs and/or documents regulatory reportability decisions on complaints in accordance with applicable local laws regulations.
• Communicates with local and international competent authorities, including generation and/or submission of medical device event reports as required by applicable local laws and regulations.
• Assists local affiliates with the preparation and submission of medical device complaints and or incident reports, when required.
• Coordinates and prepares responses to competent authority inquiry's associated with medical device report submission (Serious Injury and/or Device Malfunction).
• Participate in preparation for Notified Body audits and or Competent Authority inspections.
• When required, support root cause investigations and participates in CAPA (Corrective and Preventive Action) activities.
• Supports complaint handling trending activities.
• Generates complaint data reports for other departments, when requested.
• As required, supports department projects and/or participates in cross functional projects.
• Generates periodic reports as requested per government agencies and/or Notified Bodies.
• Performs all other duties as assigned.

Requirements:

• Bachelor's degree in scientific or business related discipline required (Biomedical, Engineering, Science, etc.) or relevant experience. 
• Knowledge of ophthalmic medical terms, Medical Device Reporting regulations, Vigilance Reporting regulations, GMPs for medical devices preferred.
• Position requires strong written, oral and listening communication skills in order to interact with customer and other professionals.
• Must be able to generate and organize clear, concise responses whencommunicating with various levels of management.
• Superior organizational skills to be able to manage challenging deadlines.
• Adjusts to change with minimum or no interruption.
• Recognizes problems and suggests applicable solutions.
• Able to perform job function with minor supervision and make independent decisions, where appropriate.
• Proficient in the use of personal computers, including database management, trending and word processing.
• Minimum of 3 years experience in quality role. 

We offer competitive salary & excellent benefits including:

• Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
• 401K Plan with company match and ongoing company contribution
• Paid time off – vacation (3 weeks - prorated upon hire), floating holidays and sick time
• Employee Stock Purchase Plan with company match
• Employee Incentive Bonus
• Tuition Reimbursement (select degrees)
• Ongoing performance feedback and annual compensation review

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please read Bausch+Lomb's Job Offer Fraud Statement.

Our Benefit Programs: https://www.bausch.com/careers/benefits/

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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