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VP, Regulatory Affairs & Quality

Company: EyeQue Corporation
Location: Newark
Posted on: January 11, 2022

Job Description:

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.

Responsibilities
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 ophthalmic technologies.
Build and manage a team of US Regulatory staff and support functions including full time staff and independent consultants, as needed.
Act as primary strategic contact with the FDA and other regulatory agencies as applicable to enable execution of company regulatory goals.
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 policies.
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 required.
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 allow.

Requirements
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 preferred.
Experience supporting commercialization and post-marketing activities and requirements for approved products in North America is preferred.
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 post-marketing activities.
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 scientific standards.
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 measures allow.
Basic experience with optometry, eye diagnostic technology, and or medical devices while not a basic requirement is most desirable.

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
Anniversary bonuses
Innovation awards
Monthly gym stipend
Unlimited snacks/drinks
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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