Perch is creating the next generation Consumer Products company by becoming the first technology-based scale operator of top eCommerce microbrands. Microbrands selling through marketplaces like Amazon are already transforming global retail - Amazon’s 3rd party marketplace alone was $300B in 2020. Perch is disrupting and accelerating this space by acquiring great brands and making them even better. We look for successful, profitable businesses that sell top-ranked products with differentiated customer feedback. The Perch platform integrates those businesses into a scale operating company and accelerates the products to the next level of sales and profitability. We are a key resource for entrepreneurs who want liquidity and a key partner for Amazon and other retail channels by offering exceptional products, great customer service, and great value.
Central to our growth ambitions is the ability to rapidly scale elements of compliance related to our products and brands. We are looking for an ambitious person to be the primary contact for matters under regulatory control associated with the Food and Drug Administration with focus on class I and II medical devices, food and personal hygiene products.
Partnering closely with the operations and the broader integration teams, the Regulatory Compliance will be responsible for oversight of products under regulatory control by the Food and Drug Administration and equivalent EU, GB and CA requirements. The ideal candidate will also have experience with RoHS, WEEE, REACH, Prop65 and other environmental regulations.
Responsibilities to include:
- Provides FDA expertise to ensure compliance with all applicable federal and state requirements (particularly CA) regulating the manufacturing and distribution of class I and II devices, personal hygiene, food and food products.
- Review potential products for correct device level classification; review of class II/III for 510(k) exemptions or make necessary filings in US, EU and Canada markets.
- Review potential products for FCC and RoHS compliance.
- Monitors manufacturing facility and product registrations.
- Assures product teams are advised of FDA requirement changes, trends and product category requirements.
- May represent Perch during on-site inspections by the FDA, customers, third party inspections and possible other government agencies.
- Assist in the maintenance of an effective Quality Management System, including relevant Standard Operating Procedures (SOPs) and Work Instructions (WIs)
- Ensure adequate follow-up through the implementation of corrective and preventative actions (CAPA) as required. All FDA / EU MDR reporting is completed.
- Provide support to currently-marketed products as necessary. This includes: reviewing labeling; reviewing promotional material; reviewing product changes; preparing documentation for changes requiring government approval; and preparing submissions and reports for regulatory agencies as required by product status.
- Be additive to our culture of challenging the status quo and having a low ego
- As required, help to interview, hire, and coach those around you
We are looking for an entrepreneurial and driven professional to help manage and buildout the FDA element of our compliance program. The ideal candidate will have several years of prior experience with FDA compliance and varied regulated commodities. They will be motivated by an opportunity to break the mold and ride the edge between speed and scalability.
Perch is one of the fastest-growing eCommerce companies in Boston. Perch acquires and develops great eCommerce brands. We are backed by amazing investors (SoftBank, Spark Capital, Tectonic Ventures, and Boston Seed). Our team has deep expertise in eCommerce, technology, and M&A. We are disrupting one of the largest and most exciting spaces of eCommerce and are building an industry-shaping platform. Our aim is to have a workplace and company that positively impacts the lives of others, including our employees, their families, the entrepreneurs and vendors we work with, and our end customers.
Perch is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.