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Form of workCooperVision, a division of CooperCompanies (NYSE:COO), is one of the world's leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com
Job Summary:
The Global RA Specialist will be involved in supporting global vigilance activities, focusing on Periodic Safety Update Reports (PSUR), with some adverse event monitoring and reporting, post-market surveillance reporting, and field safety corrective actions / recall. Support Regional Regulatory team as needed with vigilance questions. Assist in creating, developing, and implementing global Regulatory Affairs procedures and educating others on global regulatory expectations and requirements. Consistent with the corporate values, quality policy and procedures, the RA Specialist is responsible for exhibiting professional behavior with internal and external business associates that reflects positively on CooperVision, Inc.
Essential Functions & Accountabilities:
Generate Periodic Safety Update Reports (PSUR) on time and as needed.
Maintain PSUR process and templates.
Generates submissions of timely Medical Device Reporting (MDR)/vigilance reports to applicable Ministries of Health (MoHs) or Competent Authority (CA).
Generate data, draft, and maintain global post-market surveillance reports per defined timeline.
Maintains regulatory files for adverse event/incident reporting, recall, and post-market surveillance.
Continuously analyze and improve the processes utilized to manage adverse event/incident reporting, post-market surveillance, and recall.
Develop and implement and maintain standard operating procedures or work instructions as needed to ensure continued regulatory compliance.
Create monthly / quarterly / annual reports and presentations for regulatory intelligence.
Supports global and regional regulatory departments with technovigilance information.
Provide global or regional regulatory or quality assurance with support prior to or during audit from both internal and external audit bodies.
Support recall / field safety corrective action project management including liaising with internal functions such as Quality Operations, Manufacturing, Professional Services, Legal, Global and Regional Regulatory, and Marketing to provide necessary information and documentation.
Communicates with cross functional teams i.e. Professional & Medical Affairs, Clinical team in R&D, Quality Affairs and ClinicalTrials.gov.
Keeping abreast of current regulations, policies, and guidance documents.
Travel Requirements:
Able to travel approximately 5% of the time. Note that this will vary greatly from zero to 5%.
Qualifications
Knowledge, Skills and Abilities:
Excellent oral and written communication skills with diverse populations; ability to convey communication in a logical and concise polished manner.
Independent self-starter; manages time effectively and completes tasks on-time with minimal supervision. Flexible and able to self-manage multiple priorities, and ability to meet deadlines.
Strong problem solving and project management skills; ability to read, analyze, and write highly technical material.
Works scheduled hours and is ready to work at scheduled start times. Adapts readily to changes in workload, staffing, and scheduling.
Exceptional attention to detail with strong organizational skills.
Must have experience analyzing regulations and international standards.
Complies with all company policies and procedures.
Complies with management direction. Seeks assistance from supervisor in identifying and reporting problems or concerns relating to job functions.
Conducts self in a professional manner with coworkers, management, customers, and others. Models the corporate values.
Language skills (i.e., proficient in reading and writing in English)
Work Environment:
Able to work long periods of time in a normal office environment, while sitting and working on a computer.
Able to drive between General Offices and Distribution Center or Manufacturing Plant to attend meetings as needed.
Light lifting of documents, files, and reference books.
Experience:
Working knowledge of domestic and international regulations; 21 CFR, ISO 13485
Must be proficient with MS Word, MS Project, Excel (including data manipulation and graphing).
Experience in basic document control and the Agile PLM system, preferred.
Experience in the ophthalmic medical device industry, preferred.
Education:
Bachelor's degree in a scientific or technical discipline from a four-year college / university or equivalent experience in a medical device field.
Working knowledge of medical device regulations, with formal education in regulatory discipline preferred.
Regulatory Affairs Certification preferred but not required.
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