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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 Regulatory Affairs procedures; including labeling, translations, Regulatory assessments, UDI, RIMS, and corresponding training. This position will be responsible for supporting Global Regulatory product support and labeling projects. Support Regional Regulatory team as needed with labeling and packaging questions. Assist in creating, developing, and implementing Global Regulatory Affairs procedures and educating others on Global Regulatory expectations and requirements. The RA Specialist is an independent contributor who provides regulatory direction to team members. 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:
Develops and establishes strategic regulatory plans and interfaces with project team members, both within the organization and with a diverse range of external groups, to drive corporate initiatives to completion.
Generate regulatory assessment documents for product rebranding requests or post market projects, as needed.
Reviews, coordinates, and approves product labeling. Initiates new package inserts and content masters, as well as other required product labeling.
Support UDI projects and Global RA responsibilities within UDI procedures.
Proficient with CooperVision's document control system for review and approval of product labeling, variable print formats, and creation of Regulatory Assessment documents.
Maintain the Regulatory Information Management System (RIMS) procedures as well as train and support the Regional Regulatory teams as needed.
Evaluate product labeling processes for improvement.
Develops, implements, and maintains Global Regulatory procedures to ensure regulatory compliance. Trains others on new and revised procedures and performs training effectiveness checks.
Assumes a leadership role representing the perspective of Regulatory Affairs to the company. Works independently to represent Regulatory Affairs on project teams.
Supports Local Regulatory in maintaining global (domestic and international) regulatory submissions as needed, i.e. international licenses and registrations.
Maintains regulatory files and documents, in addition to internal regulatory tracking documents. This includes maintaining communication with supervisor and other departments to provide regulatory status reports (monthly, quarterly, etc.)
Keeps abreast of regulatory requirements.
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:
Minimum 1-2 years' experience in the Medical Device industry.
Prior experience in International Medical Device Regulatory Affairs a plus
In-depth understanding of Medical Device Labeling regulations including UDI.
Strong problem solving competency.
Strong project management and technical writing skills.
Effective communicator; able to convey messages in a logical and concise manner. Consistently reinforces regulatory expectations and requirements.
Ability to enter into highly different cultural and regulatory backgrounds worldwide with 'diplomatic sensitivity'.
Exceptional attention to detail with strong organizational skills.
Independent self-starter; manages time effectively and completes tasks on-time with minimal supervision. Flexible and able to self-manage multiple priorities.
Able to work effectively in multinational/multicultural environments.
Works scheduled hours and is ready to work at scheduled start times. Adapts readily to changes in workload, staffing, and scheduling.
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.
Proficient with MS Word Office Suite for PC, Adobe Acrobat XPro. MS Project, VISIO, RIMS, and Esko experience a plus.
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:
1-2 years in the medical device industry with experience in Regulatory Affairs or related field. Medical device regulatory submissions writing and technical writing experience a plus. Has experience representing Regulatory Affairs on cross-functional project teams.
Proficient with MS Word Office Suite for PC, Adobe Acrobat XPro. MS Project, VISIO, RIMS, and Esko experience a plus.
Education:
Bachelor's degree in a scientific or technical discipline from a four-year college or university. Working knowledge of medical device regulations, with formal education in regulatory discipline preferred.
Regulatory Affairs Certification preferred but not required.
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