DESCRIPTION 

At quip, we design and deliver delightful products and services that keep your mouth healthy. 

As a Product Compliance &Regulatory Affairs Manager on the Operations team, you will own all aspects of product and market regulatory compliance, globally, across quip’s portfolio of hardware, consumable, and services products. You will own the relationship with regulatory bodies that include the FDA and ADA. This individual will be accountable for the design and implementation of new processes to achieve and maintain regulatory compliance in all international markets.

The ideal candidate would have extensive experience establishing and maintaining regulatory compliance processes and systems, supporting product development, and working directly with both domestic and international regulatory bodies.

Base Salary: 120-135k

This range represents anticipated base salary range for this position, in addition to competitive benefits and equity (as applicable). We carefully assess and consider several factors with each candidate, including location, role-related knowledge, experience and skills. Compensation may vary based on these considerations.

Responsibilities

• Ensure and maintain relevant company, product, and supply chain regulatory compliance for Medical Devices, OTC Drugs, Food Products, RX, as well as other products and services
• Lead evolution of Quality Management System and associated processes to support product, market, company, and business growth
• Review product labeling, packaging, advertising, marketing, digital materials for compliance to regulatory requirements
• Responsible for all regulatory aspects of NPD from concept to certification through maintenance / renewals
• Provide direction for regulatory marking and documentation requirements on products and packaging, examples include FCC, UL, CE, RoHS, REACH, WEEE, Prop 65, and EMC/EMI
• Support 3rd party safety and compliance evaluations and testing tasks in accordance with project timelines
• Manage the documentation, preparation, signature, timely submittal, sharing, and proper archival of all regulatory product compliance technical documentation for new products and certification renewals
• Maintains updated knowledge of national and international regulations, guidance, and standards related to product and service offerings and proactively take actions to assure product compliance as standards change
• Fosters and manages a relationship with the FDA, Notified Bodies and international regulatory authorities, owning both communications and interactions with various governmental agencies/regulators
• Influence all levels of the organization and regulatory bodies. Present both verbally and orally as needed. Includes presentations to upper management, training, audits presentations, business communications, investigation summaries, and audit reports
• Lead supplier, internal, and certification/maintenance audits, as needed
• Reviews customer complaints and establishes/follows regulatory reporting requirements

Requirements

• 7+ years regulatory management experience of Medical Devices and OTC drugs
• Telehealth experience and familiarity a plus 
• Experienced leading interactions with Notified Bodies and agencies including the FDA
• Expert knowledge of FDA 21 CFR, ISO 13485, ISO 9001, and Medical Device Single Audit Program (MDSAP)
• Experience with FDA monographs, CE, UL, FCC, and Dental Associations (i.e ADA) a plus
• Track record of building, expanding, and maintaining company quality systems
• Experienced leading certification, internal, and supplier qualification audits
• Ability to pass background check and meet state requirements to supervise RX medical device distribution
• Strong facilitation skills and building cross-departmental alignment
• Excellent communication (written and oral) and interpersonal skills required

BENEFITS

• You’ll be working in a high energy, fast paced environment helping us make oral care simple and effective!
• Flexible hybrid schedule - mix of in-office and remote working options
• An office located in the heart of DUMBO with breathtaking views of Manhattan Bridge
• Fully covered health insurance (with an option to opt into a premium internal dental program)
• Commuter benefits for parking & transit
• Offer competitive paid parental leave policy for qualifying employees
• Open vacation policy
• 401k benefits
• Employee Bonus Referral Program
• Extended Education Assistance Program
• Dog friendly office space
• Fully stocked kitchen with snacks (make sure to use your quip after snacking!)
• Your very own quip with an unlimited subscription plan
• The opportunity to help us make oral care more simple, effective and accessible!

About quip

quip is a modern oral health company launched in 2015 that provides thoughtfully designed personal oral care products and professional dental care services through a digital platform that makes oral care more simple, accessible, and enjoyable. The current personal care offerings include a wide selection of American Dental Association accepted (ADA seal) adult and kid electric toothbrushes, smart brushes, refillable floss pick and string, refillable mouthwash and gum, all kept fresh with a refill delivery service. quip’s professional platform, which is behind quip Aligners and quipcare, is part of the company’s future vision to connect personal care, oral health monitoring and professional care in one digital oral care companion app that helps access and manage all your oral care needs and guide and incentivize good oral health habits.

quip is committed to promoting equality, inclusion, and diversity beyond your brushing routine. We believe our company is better equipped to care for every mouth when we listen to fresh perspectives from every voice, and in doing so, we build an equal-opportunity team of the brightest minds (and mouths)—regardless of race, gender, age, religion, sexual orientation, identity, or any other trait that makes you you. By celebrating and supporting our differences, we will thrive in our mission to improve oral health for all.