Product Compliance & Regulatory Affairs Manager

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

• Support 3rd party safety and compliance evaluations and testing tasks in accordance with project timelines
• 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
• 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
• Fosters and manages a relationship with the FDA, Notified Bodies and international regulatory authorities, owning both communications and interactions with various governmental agencies/regulators
• Lead evolution of Quality Management System and associated processes to support product, market, company, and business growth
• 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
• Review product labeling, packaging, advertising, marketing, digital materials for compliance to regulatory requirements
• Manage the documentation, preparation, signature, timely submittal, sharing, and proper archival of all regulatory product compliance technical documentation for new products and certification renewals
• Reviews customer complaints and establishes/follows regulatory reporting requirements
• Responsible for all regulatory aspects of NPD from concept to certification through maintenance / renewals
• 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

Requirements

• Degree in relative field Mechanical, electrical, industrial, software, automation background preferred
• Strong facilitation skills and building cross-departmental alignment
• 7+ years regulatory management experience of Medical Devices, Consumer Electronics and OTC drugs
• Experience working with manufacturers and suppliers; nice to have
• Experienced leading interactions with Notified Bodies and agencies including the FDA
• Experience with FDA monographs, CE, UL, FCC, and Dental Associations (i.e ADA) a plus
• Excellent communication (written and oral) and interpersonal skills required
• Expert knowledge of FDA 21 CFR, ISO 13485, ISO 9001, and Medical Device Single Audit Program (MDSAP)
• Experienced leading certification, internal, and supplier qualification audits

BENEFITS

• Fun and inclusive culture! We offer People Resource Groups including quip Pride and quip Womxn’s Network and Interest Groups like quip Book Club.
• Free dental benefits as part of quip's Dental Program (NYC Residents)
• Quip Swag
• Pet-friendly office
• Employee Referral Bonus Program
• Pre-Tax Commuter Benefits (~30% savings)
• Competitive paid parental leave policy
• High potential for growth in a start-up atmosphere
• Competitive medical benefits, quip covers 95% of medical coverage for employees, starting your first day of employment.
• Open Vacation Policy
• An office located in the heart of DUMBO with breathtaking views of Manhattan Bridge
• $400 incentivized gym reimbursement through our insurance
• Employee Assistance Program, including mental health resources
• Fully-stocked kitchen with kombucha, cold brew, and beer on tap
• Team and company happy hours
• Sequoia Smartspend, offering discounts on things like travel, car rentals, cell phone plans, home goods, pet insurance, and more.
• Computer and supplies provided
• Dependent care FSA
• You'll be working in a high energy, fast-paced environment helping us make oral care simple and effective!
• Entire quip product line, refill plan, and employee discount

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.