Senior Regulatory Affairs Specialist

Job Description

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 Sr. RA Specialist provides support for the regulatory department to ensure efficient and compliant business processes and environment. Partner across business functions assisting in identifying data needed, obtaining required documentation, and ensuring that submissions are effectively presented for product registrations.

Responsibilities

• Leads the preparation and submission for regulatory approvals and acts independently to identify and resolve problems.
• Thoroughly assess documents, interpret findings, organize information, and present summarized results for inclusion in regulatory submissions (510(k) and PMA).
• Review and approve device labeling and marketing materials for compliance with applicable regulations.
• Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle.
• Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
• Authors regulatory documents under minimal supervision and serves as in-house regulatory expert to internal and external stakeholders.
• Develop the regulatory strategy and filing strategy for manufacturing, facility changes and R&D activities under minimal supervision.
• Acts as regulatory liaisons and single point of contact in meetings and interact with members of the project team for assigned projects.
• Keep abreast of new or revised regulations, guidelines, points to consider, etc.
• Follows 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.
  
  
  

CooperVision’s management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.

Qualifications

Knowledge, Skills and Abilities:

• Excellent oral and written communication skills, with ability to communicate with diverse populations. Able to convey messages in a logical and concise manner.
• Demonstrate a proven ability in technical/medical reading and writing, with a focus on checking technical content for consistency and accuracy.
• Experience working with Class II and III medical devices.
• Must be proficient with Microsoft Office including the ability to develop MS PowerPoint presentations and Excel spreadsheets (including data manipulations and graphing).
• Ability to read and understand highly technical material.
• Ability to meet deadlines.
• Strong problem-solving competency.
• 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.
  
  
  

Work Environment:

• Professional or remote office environment.
• Willing to travel to various offices across the US.
• Willing to work in a fast-paced environment.
• Light lifting of documents, files, and reference books.
  
  
  

Experience:

• 5+ years of experience in an FDA regulated industry required; preferably with medical devices.
• Ability to develop innovative strategies and creative solutions within the regulatory context within the scope of global requirements and available resources.
• Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
• Ability to analyze and resolve non-routine regulatory issues using independent judgement.
• Working knowledge of US regulations and guidance including but not limited to FDA 21 CFR 820, MDSAP, and ISO 13485.
• Strong initiation and organizational skills.
• Previous experience working in a geographically diverse business environment.
  
  
  

Education:

• Bachelor’s Degree from a four-year college or university.
• Working knowledge of medical device regulations, with formal education in regulatory discipline preferred.
• RAPS Certification (RAC) experience is a plus.
  
  
  

Affirmative Action/Equal Opportunity Employer. Minority/Female/Disability/Veteran

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $81,372.00 and $108,496.00 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.