Global Regulatory Affairs Specialist - Contractor

CooperVision, a division of CooperCompanies (NASDAQ: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 supports Global Regulatory with packaging and labeling project activities. The Global RA Specialist assists in developing regulatory strategies for assigned corporate projects, with a strong focus on product labeling. This role is an independent contributor responsible for reviewing artworks and coordinating with Global and Regional RA team members. In alignment with corporate values, quality policies, and procedures, the Global RA Specialist is expected to demonstrate professional behavior with internal and external business associates, reflecting positively on CooperVision, Inc.

Responsibilities

• Support established strategic regulatory plans and interface with project team members to drive corporate initiatives to completion. 
• Generate regulatory documents as needed. 
• Review, coordinate, and approve product labeling; initiate new required product labeling. 
• Evaluate product labeling for impact on global regulatory approvals, clearances, registrations, and licenses. 
• Be proficient with CooperVision’s document control system for review and approval of product labeling, variable print formats, and creation of Regulatory Assessment documents. 
• Work independently and think critically. 
• Support Local Regulatory in maintaining global (domestic and international) regulatory submissions as needed, e.g., international licenses and registrations. 

Maintain regulatory files and documents, as well as internal regulatory tracking documents. This includes maintaining communication with the supervisor and other departments to provide regulatory status reports (monthly, quarterly, etc.). 

Travel: <5% domestic and international travel

Qualifications

Knowledge, Skills and Abilities:

• Working knowledge of regulations and guidance governing medical device preferred. 
• Excellent collaboration/relationship building, strong influencing and negotiation skills, integrity and adaptability.
• Outstanding written and oral communication skills as well as managing and adhering to timelines. 
• Understand and interpret complex regulatory requirements and strategy.  
• Working of knowledge of Microsoft Office Suite. Experience with Agile preferred.
• Technical writing and analytical skills
• Conduct self in a professional manner with coworkers, management, customers, and others.
• Strategic and critical thinking, communication, attention to detail, self-motivation
• Ability to read and understand technical, complex material

Work Environment:

• Normal Office environment. Prolonged sitting in front of a computer.
• Should possess skills to utilize the concept of continuous improvement, change management and employee teams. Ability to work with a diverse workforce.
• Knowledge of Good Documentation Practices.
• This is a 5 day in-office temporary contract role based in Victor, NY, USA.

Experience:

• 1-3 years of experience with quality, regulatory, or transferrable skills (i.e. scientific background) preferred 
• Medical Device industry experience preferred; other regulated industry experience considered

Education:

• Bachelor of Arts degree, or equivalent, accepted based on experience. Bachelor of Science degree, or equivalent, preferred.
• Medical Device industry experience preferred; other regulated industry experience considered

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $25.00 and $28.00 per hour 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.

#LI-AK1