Medical Device, Quality/Risk Management, Research & Development, Worldwide Regulatory Affairs
4 Year Degree
The Senior Regulatory Affairs (RA) Specialist will provide regulatory support and direction to products from concept to launch. The Sr. RA Specialist follows the regulatory strategy for assigned corporate projects. Assists in creating, developing, and implementing global regulatory affairs procedures for marketed products and to ensure company’s regulatory compliance status.
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Use Regulatory Affairs Impact Document (RAID) process as a base product lifecycle RAID with revision control and central files. Collaborate with the manufacturing sites and global RA functions to review the completed RAIDs and ensure RAIDs are properly approved and filed.
Evaluate proposed product modifications for regulatory impact. Complete RAIDs as needed.
Maintain regulatory files and documents. This includes maintaining communication with supervisor and other departments to provide regulatory status reports.
Supply samples, packaging, and assist in scheduling and managing outside testing labs and CRO activities.
Utilize project tools to effectively track and communicate project development to meet agreed upon schedules. Maintain and use the global RA database reporting functions reporting key performance indicators (KPIs) and rollout plans to global RA team and management.
Implement and execute on regulatory plans and interface with project team members, both within the organization and with a diverse range of external groups, to drive corporate initiatives to completion.
Represent global RA and support RA project core team members on development teams providing RA guidance and project regulatory assessments. Serve as representative for Design Review Boards consisting of review/approval of Design Control documentation to support the project through the Design Control process.
Liaise with internal functions such as manufacturing, R&D, operations and marketing to provide necessary information and documents [outside the Master Technical Files (MTFs) and Master STEDs (MSTEDs)] requested by the regions to assist in global product registration activities. Create MTFs and MSTEDs for each product/project in Design Control.
Independently manage multiple projects, department initiatives, and day to day tasks.
Keep abreast of regulatory requirements, this includes monitoring FDA and other global agencies regulations and standards.
Respond to corporate inquires and follow up for internal processes.
KNOWLEDGE, SKILLS AND ABILITIES:
5+ years of medical device regulatory experience
Technical writing experience. Have experience evaluating manufacturing changes for impact on global regulatory affairs submissions.
Medical device industry experience including strong working knowledge and experience with US FDA and EU. International medical device industry understanding would also be very helpful for this position.
Working knowledge of US regulations and guidance including but not limited to FDA 21 CFR and ISO 13485.
Experience in basic document control and the Agile PLM system is a plus yet not required.
Strong computer skills, problem solving ability, analytical and communication skills
General office environment.
Due to nature of work, there are prolonged periods in front of a computer and on teleconferences.
A certain level of travel and attendance at business meetings both domestic and internationally is required.
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.
RAPS certification (RAC), ASQ and or ISO13485 certified auditor and/or QA Manager experience a plus.
Experience working in the Optical industry, specifically contact lenses and Soft Contact Lens Eye Care Solutions field, is a plus.
At least 5 years working in a medical device regulatory affairs role with natural progression evident in career history.
Internal Number: RD0125
About CooperVision, Inc.
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.