Global Regulatory Specialist

Who We AreFrida is more than a brand built to support parents. We get parents. We know all about the often unbelievable realities of parenthood, because we’ve been in the trenches. Over the last 9 years, we’ve dedicated ourselves to developing the tools (and sometimes the tips, too) that help simplify parenting - and it all started with snot. Since the launch of our cult-favorite NoseFrida, The SnotSucker, we’ve innovated and launched over 100 products that provide quick and easy solutions to age-old parenting problems. We also launched Frida Mom in 2019, with products to help women with the transition through the fourth trimester into motherhood. Today, Frida holds over a 70% share of its main category, and our products can be found in over 50+ countries and in over 40,000 stores throughout the US - in every retail channel from mass-market, grocery, chain drug, and specialty stores. For 9 years, we’ve had parents’ backs as they navigate the parts of parenthood you don’t usually see on the ’gram with honest and raw messaging to provide the answers to questions they didn’t even know they had. And, we’re just getting started.How You Will Make an ImpactFrida is seeking a Global Regulatory Affairs Manager to join our Quality and Regulatory team that takes the lead in ensuring that Frida's operations adhere to the laws regulating the CPG and medical device industries globally. The right person will have knowledge of FDA, GxP and CPSC regulations as well as be able to navigate the regulations of their global counterparts (Canada, Mexico, EU, UK, Switzerland, Saudi FDA, etc.).

This person will manage regulatory responsibilities associated with product development, support and manufacturing of the company’s medical device, OTC and general use products, including but not limited to: product registrations, license renewals,

resolving compliance issues, staying abreast of regulatory changes, and liaising with outside parties to ensure compliance in global markets. Responsibilities to include:

Manage the development and implementation of regulatory strategies and plans to support the timely introduction of new products and the preparation/review of international regulatory submission(s) (EU MDR Tech File, Health Canada submission, Saudi FDA, etc)Represent international regulatory interests on cross-functional project team for new and existing productsReview and approve labeling requirements for global market(s); translation material, claims review, IFU, etc.Evaluate change proposals for international regulatory impactMaintain effective communication within the RA/QA group, as well as, cross-functional business partners, i.e. Product Development, Marketing, Legal, etc.Support Regulatory and Quality Departments efforts in maintaining ISO 13485 and MDSAP Certifications (internal audit, NB audits, SOP compliance, etc)May provide direct supervision of individual(s)What You Will NeedBachelor's degree in Science, Engineering, Pharmaceutical discipline(s)Direct experience with international regulatory affairs (submissions, License renewals, TF, etc.)A minimum of 3 years in a medical device, pharmaceutical or similar organizationAbility to handle competing priorities and deadlinesHighly organized, meticulous with a great attention to detailAble to work independently as well as in teamsResult-oriented, creative and able to multitaskGreat communication skills both verbally and writtenExperience of working within the requirements of 21 CFR 820, ISO 13485, MDSAP, the Medical Devices Directive (93/42/EEC) and European Medical Device Regulation 2017/745.Who You Will Work WithFrida is an organization that values collaboration and community. As the Global Regulatory Specialist, you will work closely with Brand Management, Project Management, Marketing, and Sourcing teams.Our Ways of WorkingFrida HQ is located in Miami, Florida and approved roles have the flexible option to work remotely both Mondays and Fridays with the benefit of connecting in person Tuesdays - Thursdays.Why You Will Love Working at FridaRobust health benefits including:Comprehensive medical, vision, and dental plansEmployer paid life insuranceSupplemental insurance options including Accident Insurance, Short-Term Disability and Long-Term DisabilityFSA & HSA401k matching up to 4% with immediate vestingGenerous paid time off program including elective PTO days, federal holidays, sick/wellness days, and a birthday floaterFlexible paid pregnancy and parental leaveWeekly wellness programming including manicures & pedicures, massages, and carwashesDog friendly office - feel free to bring your best buddy with you to work!Learning & development opportunities for professional and personal growthCompany-wide events & outings- we know how to throw a party! Team engagement is at the epicenter of our culture, whether it’s getting together for our annual Fam Jam bash or giving back to our community through a day of serviceExclusive employee product discounts

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