CooperVision · 3 days ago
Regulatory Affairs Specialist - Regional
San Ramon, CA
Full-time
Onsite
Entry, Mid Level
$86K/yr - $114K/yr
2+ years expCooperVision is a leading global manufacturer of contact lenses dedicated to improving vision. The Regulatory Affairs Specialist will combine scientific, regulatory, and business issues to ensure compliance with local regulations and facilitate the approval of products.
Health CareManufacturingMedical Device
Hiring Manager
Arifa I Kazmi, PHR
Responsibilities
Evaluates manufacturing changes for impact on North America regulatory affairs approvals, clearances, registrations, and licenses
Prepares FDA submissions and Health Canada applications for regulatory approvals
Reviews and approves device labeling for compliance with applicable regulations
Responsible for registration submission management in the Regulatory Information Management System
Maintains Health Canada Medical Device Establishment Licenses (MDEL) and Annual Medical Device License (MDL) Renewals
Provides regulatory guidance and support to Canadian private label customers such as, but not limited to, assisting with private label applications and amendments
Prepares Summary Reports in compliance with Health Canada regulations
Must assure that all deadlines are met and provide effective leadership without direct authority
Responds to corporate inquiries and follow up to internal processes
Keeps abreast of regulatory requirements, this includes monitoring FDA and Health Canada regulations and standards
Maintains communication with supervisor and other departments to provide regulatory status reports
Qualification
Required
2-4 years of experience in an FDA regulated industry required, preferably with medical devices
Experience evaluating manufacturing changes for impact on North America submissions
Experience in using Veeva Regulatory Information Management (RIM) System
Working knowledge of US regulations and guidance including, but not limited to, FDA 21 CFR 820, MDSAP, and ISO 13485
Strong working knowledge and experience with US FDA and Health Canada submissions
Previous experience working in a geographically diverse business environment
Bachelor's Degree from a four-year college or university
Excellent oral and written communication skills, with ability to communicate with diverse populations. Able to convey messages in a logical and concise manner
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
Preferred
Working knowledge of medical device regulations, with formal education in regulatory discipline preferred
RAPS Certification (RAC) experience is a plus
Company
CooperVision
CooperVision is one of the world’s leading manufacturers of soft contact lenses and related products and services. It is a sub-organization of The Cooper Companies.
5001-10000 employees
H1B Sponsorship
CooperVision has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (12)
2023 (14)
2022 (7)
2021 (13)
2020 (11)
Funding
Current Stage
Late StageLeadership Team
Michael Good
Divisional Chief Financial Officer
Recent News
2026-01-06
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2025-09-28
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