Regulatory Affairs Specialist - Regional

The Cooper Companies•San Ramon, CA

66d•Onsite

About The Position

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: The Regulatory Affairs Specialist will be responsible for combining scientific, regulatory, and business issues to enable projects that are developed, manufactured, and distributed to meet local regulations and requirements.

Requirements

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.
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.
Working knowledge of medical device regulations, with formal education in regulatory discipline preferred.

Nice To Haves

RAPS Certification (RAC) experience is a plus.

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.