CooperVision, a unit of The Cooper Companies, Inc. (NYSE:COO), is one of the world's leading manufacturers of soft contact lenses and related products and services. The Company produces a full array of monthly, two-week and daily disposable contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism and presbyopia; 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 TITLE: Regulatory Affairs Specialist - CONTRACT
DEPARTMENT: Regulatory Affairs
The RA Specialistsupports Global Regulatory Compliance Manager with packaging and labelingproject support. Support RegionalRegulatory team as needed with labeling and packaging questions related toglobal regulatory submissions. The RA Specialist is an independent contributorwho provides regulatory direction to team members. Thisis a 6 month contract with a possible 6 month extension.
Consistent with the corporate values, quality policyand procedures, the RA Specialist is responsible for exhibiting professionalbehavior with internal and external business associates that reflectspositively on CooperVision, Inc. The individual conveys a trustworthy,credible, and reliable image
Generate regulatory assessment documents forproduct rebranding requests or projects.
Reviews, coordinates, and approves product labelingand marketing material. Initiates new package inserts and other requiredproduct labeling.
Evaluates product labeling and manufacturingchanges for impact on global regulatory affairs approvals, clearances,registrations, and licenses.
Proficient with CooperVision's document controlsystem for review and approval of product labeling, variable print formats,Ad/Promo pieces, and creation of Regulatory Assessment documents.
Evaluate product labeling processes forimprovement.
Tracks Global rollout of product approvals forproduct changes and updated labeling and provides updates to Life CycleManagement and Supply Chain.
Develops, implements, and maintains globalregulatory procedures to ensure regulatory compliance. Trains others on new andrevised procedures and performs training effectiveness checks.
Supports Local Regulatory in maintaining global(domestic and international) regulatory submissions as needed, i.e.international licenses and registrations.
Maintains regulatory files and documents, inaddition to internal regulatory tracking documents. This includes maintainingcommunication with supervisor and other departments to provide regulatorystatus reports (monthly, quarterly, etc.)
Keeps abreast of regulatory requirements, thisincludes monitoring FDA and other agencies regulations and standards
KNOWLEDGE, SKILLS AND ABILITIES
In-depth understanding of Medical Device Labelingregulations.
Strong problem solving competency.
Strong project management and technical writingskills.
Effective communicator; able to convey messages ina logical and concise manner. Consistently reinforces regulatory expectationsand requirements.
Ability to enter into highly different cultural andregulatory backgrounds worldwide with 'diplomatic sensitivity'.
Exceptional attention to detail with strongorganizational skills.
Has depth of experience reviewing and approvingproduct advertising and creating product labeling.
Independent self-starter; manages time effectivelyand completes tasks on-time with minimal supervision. Flexible and able toself-manage multiple priorities.
Able to work effectively inmultinational/multicultural environments.
Works scheduled hours and is ready to work atscheduled start times. Adapts readily to changes in workload, staffing, andscheduling.
Complies with all company policies and procedures.
Complies with management direction. Seeksassistance from supervisor in identifying and reporting problems or concernsrelating to job functions.
Conducts self in a professional manner withcoworkers, management, customers, and others. Models the corporate values.
Strong mathematical, analytical, and computerskills.
Strong working knowledge of domestic and internationalregulations; 21 CFR 801 Labeling, ISO11978, Medical Device Regulation (MDR) and other regulations that affect ClassII and III medical device registration.
Able to work long periods of time in a normaloffice 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.
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.
1-2 years in the medical device industry withexperience in Regulatory Affairs.
Proficient with MS Word Office Suite for PC and
Adobe Acrobat XPro. Esko experience a plus.
The Cooper Companies