VP, Regulatory Affairs & Quality
Company: EyeQue Corporation
Posted on: January 11, 2022
EyeQue is on a global mission to elevate eye care. Headquartered
in Newark, CA, EyeQue is a mid-stage start-up closing its Series C
round financing. EyeQue inspires consumers to learn about and care
for their eyes by putting affordable, accurate vision tests
directly into their hands. Based on exclusive revolutionary
patented technology, EyeQue is bringing self-administered eye tests
to billions of people around the world, many of whom would not have
had the opportunity to test their eyes and correct their vision
without access to this low cost, convenient solution. EyeQue won 5
CES awards in the last 4 years and was voted #1 best startup in
Newark two years in a row! This is a highly visible leadership
position in the company and will report directly to the Founder &
President of EyeQue.
Provide strategic leadership for regulatory strategy, agency
interactions, and submissions in the USA and globally.
Provide leadership and oversight for all regulatory submissions,
regulatory compliance, regulatory advice and counseling in all
areas of development, and commercial regulatory activities across
the lifecycle of products in the USA and globally.
Foster a strong relationship, partnership and advocacy with FDA and
Global Health authorities, including as it relates innovation in
Build and manage a team of US Regulatory staff and support
functions including full time staff and independent consultants, as
Act as primary strategic contact with the FDA and other regulatory
agencies as applicable to enable execution of company regulatory
Provide strategic and tactical direction to drive cross-functional
consistency in regulatory approach and execution.
Provide direct regulatory oversight to all applicable clinical and
CMC activities (development and commercial).
Support product launch and commercialization activities.
Provide counsel, training, and interpretation of FDA and other
regulatory guidelines or issues to Company personnel and assist as
a liaison between the Company and regulatory authorities.
Keep peers and superiors apprised of expected changes to the
regulatory landscape affecting existing and future regulatory
Lead the compilation, review, and submission of all CTAs, marketing
applications and/or post approval amendments.
Develop and design robust regulatory structures, processes and
procedures based on expert understanding, industry experience, and
insight into future direction.
Support medical affairs, advertising and promotion activities and
corporate communication activities, including review of
publications and investor relations/legal public disclosures as
Provide guidance to business development regarding critical
evaluation of potential product opportunities supporting strategic
partnering and licensing activities.
Develop and plan innovative regulatory strategies for label
enhancements and life cycle product management.
Provide regulatory strategic leadership supporting
commercialization and post-marketing activities and requirements
for approved products.
Provide regulatory review and approval of product labeling,
promotional claims and advertising to ensure compliance with
corporate policy, US and international laws and regulations
Ability to travel up to 25% when public health & safety measures
Education: Minimum Bachelor's degree with a focus in life sciences
or related; an advanced degree is strongly preferred.
Experience: Minimum 10 years of experience Regulatory Affairs
within the medical device industry with 7 years of specific
leadership and/or management experience.
Experience leading, designing, writing, submission of regulatory
filings and correspondence and/or approvals is required, including
within the Optometry/Ophthalmology space.
Experience leading the submission process for FDA regulatory
approvals, new entities and line extensions of existing products
Experience supporting commercialization and post-marketing
activities and requirements for approved products in North America
Strong collaboration, leadership competencies and strategic
business perspectives are required to ensure that sound research,
development, regulatory and compliance practices are fully
integrated in all clinical studies, clinical development and
Other Skills and Abilities: Strong understanding of the global
medical device development and regulatory environment, particularly
within the FDA.
Experience and/or active involvement in joint ventures, highly
collaborative partnerships, and in/out-licensing business
opportunities is a plus.
Must be able assimilate and interpret trends in the US healthcare
policy environment that directly affect business decisions in the
optical science, digital health, and biotech industry.
Must have excellent oral and written communications skills as well
as the ability to build cross-functional relationships and work
collaboratively with other groups.
Must demonstrate a firm commitment to achieving corporate
objectives while maintaining the highest ethical, regulatory and
Entrepreneurial, innovative, energetic, hands-on, team oriented,
and customer focused, with the ability to think strategically as
well as execute project details.
Must be able to commute to Newark, CA when public health & safety
Basic experience with optometry, eye diagnostic technology, and or
medical devices while not a basic requirement is most
Compensation / Benefits
Competitive base salary and performance-based bonuses
Employee Stock Options
401(k) plan with 3% company contribution
Comprehensive health benefits with company-paid premiums
10 company holidays and 13 PTO days a year
Flexible work schedule
Employee discounts for glasses and EyeQue store products
Monthly gym stipend
What a great place to work!
Job Type: Full-time
Keywords: EyeQue Corporation, Newark , VP, Regulatory Affairs & Quality, Executive , Newark, California
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