CooperVision, 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 Regulatory Affairs Coordinator provides support to the VP, Regulatory Affairs and the Global Regulatory Affairs team in the areas of documentation, submission formatting, and samples/labelling to support regulatory filings. As a key contact within the department and externally, the individual operates in a manner consistent with the corporate values, quality policy, and procedures. The RA Coordinator is responsible for exhibiting professional behavior with internal and external business associates that reflects positively on CooperVision, Inc. The individual conveys a trustworthy, credible, and reliable image.

Essential Functions & Accountabilities:

• Interfaces with management and department.
• Demonstrates proficiency and experience in document collation/organization. In addition to the required technical documentation, supplies samples, packaging, manufacturing site quality system certificates, and certificates of free sale, etc. for global product registrations.
• Team support for invoices, PO admin, room bookings, etc.
• Supports the storage and maintenance of regulatory information.
• Facilitates the effective communication of regulatory information, both within Regulatory Affairs and across the wider business.
• Performs general data maintenance.
• Prepares monthly metrics from searches.
• Maintains contracts and invoice coordination with respect to Regulatory requirements.
• As business needs dictate, works extended hours to complete daily department goals or tasks to include mandatory overtime.

Travel Requirements:

• No significant travel. Occasional requirements to attend offsite meetings.

Qualifications

Knowledge, Skills and Abilities:

• Be an effective communicator; able to convey messages in a logical and concise manner
• Have attention to detail with organizational skills
• Be an independent self-starter; manages time effectively and completes tasks on-time with general supervision. Be flexible and able to self-manage multiple priorities.
• Work scheduled hours and is ready to work at scheduled start times. Adapts readily to changes in workload, staffing, and scheduling
• Complies with 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 colleagues, management, customers, and others. Models the corporate values.
• Mathematical, analytical, and computer skills. Proficiency in Word, Excel, PowerPoint, Visio, etc.

Work Environment:

• Able to work long periods of time in a normal office environment, while sitting and working on a computer.

Experience:

• Some work experience in a Regulatory Affairs or medical device/pharmaceutical manufacturer environment preferred, or internship, but not essential. Financial or legal knowledge would be advantageous.

Education:

• Requires a college or University degree or the equivalent work experience.

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $62,285 and $83,046 and may include cost of living adjustments. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.

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