- Professional
- Optionales Büro in Victor
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.
Scope:
As an individual contributor, the Regulatory Affairs (RA) Specialist acts as a link between the company and regulatory authorities, ensuring that products are distributed in compliance with local regulations. The individual will identify data needed, obtain data, and ensure they are effectively presented for the registration of products in North America.
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.
Responsibilities
Essential Functions & Accountabilities:
- 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.
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.
- 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 office environment.
- Willing to report to work at the San Ramon or Victor office.
- Willing to work in a fast-paced environment.
- Light lifting of documents, files, and reference books.
Experience:
- 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.
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.
For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $47,368.00 and $63,157.00 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.
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