Senior Specialist, Global Regulatory Systems

At CooperVision, a division of CooperCompanies, we’re driven by a unifying purpose to help people to experience life’s beautiful moments. We are connected through our shared values - dedicated, innovative, friendly, partners, and do the right thing. As a leading global manufacturer of contact lenses, we are committed to helping improve the way people see each day. Through our diverse lens portfolio, we tackle the toughest vision challenges – including astigmatism, presbyopia, and childhood myopia. We offer the most complete collection of spherical, toric, and multifocal products available, enabling us to fit 99% of all contact wearers. Learn more at www.coopervision.com.

Job Summary:
Supports RA teams in the use of regulatory systems, including Veeva Vault RIM, to enable global product registrations and regulatory activities. Ensures consistent system utilization, resolves user issues, and supports integration with other systems (e.g., eQMS, Agile). 

Responsibilities

Essential Functions & Accountabilities:

Supporting RIM or other systems:

• Support implementation and improvement of regulatory systems and processes, including: 
  • Veeva Vault RIM (communication, adoption, roadmap support, best practices)
  • Acts as the Change Agent providing Technical documentation for submissions
  • Source of Truth (SOT) data management
  • Unique Device Identification (UDI)
• Serve as Veeva Vault RIM Business Administrator in coordination with IT
• Provide user support, training, and change management
• Partner with regional RA teams to identify and implement system improvements
• Support system integration with platforms such as eQMS
• Ensure required documentation is available within systems and aligned with QMS
• Liaises with other, non-RA internal functions to assist with ensuring that all documentation required to support global product registration activities is adequately embedded in the QMS and is available in the RIM system for end users
• Monitor system usage and support global registration activities
• Develop and track system performance metrics
• Investigate and resolve system-related issues using QMS processes
• Maintain audit-ready documentation

Registration Activity – supporting regional RA activities:

• Assist with preparation and submission of regulatory documentation for assigned markets

• Collaborate with agencies, consultants, and partners to ensure complete and accurate submissions
  May assist with preparation, compilation, and submitting regulatory documents for the registration of current and new products in assigned markets, as agreed with regional RA leadership. 

   

Monitoring Registration Requirements:

• Identify regulatory requirements with regional RA representatives
• Maintain knowledge of applicable regulations and standards
• Communicate regulatory requirements and assess impact of changes

Support to CooperVision Processes:

• Represent regulatory perspective across the organization
• Provide guidance on regulatory and quality matters to minimize risk and improve outcomes
• Deliver training and support
• Other duties as assigned

Travel: 

• Up to 10% domestic or international travel 
   

Qualifications

Knowledge, Skills and Abilities:

• 5+ years in medical device or pharmaceutical regulatory environment (preferred)
• Bachelor’s degree in scientific or technical field required
• Advanced degree or Regulatory Affairs Certification preferred
• Knowledge of global regulatory requirements (FDA, ISO, MDSAP, Health Canada, LATAM)
• Experience with regulatory systems (e.g., Veeva Vault RIM)
• Experience in technical documentation and document management systems
• Strong written and verbal communication skills
• Experience interpreting regulations and international standards
• Process improvement experience within regulatory or quality systems
• Experience with change control and change management
• Strong project management, technical writing, analytical, and problem-solving skills
• Independent self-starter; manages time effectively
• High attention to detail and organization
• Ability to work independently and across global teams including adjust work schedule to adapt to different time zones, as needed. 
• Knowledge of medical device regulations required; or ISO standards preferred
• Veeva Vault Business certification (or ability to obtain)
• Proficient in Microsoft Office (Excel, Project, Visio) and Adobe Acrobat
• Fluent in English

Work Environment:

• Office-based with extended computer use
• Onsite 5- days a week in office
   

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $91,928.00 and $122,570.00 per year 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.

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.