Regulatory compliance activities for medical devices and other regulated products distributed in the United States, Canada, European Union, and other applicable markets are supported by the Regulatory Affairs Specialist. This position maintains product and establishment registrations, evaluates regulatory requirements, reviews product labeling and claims, supports new product introductions and product changes, maintains regulatory documentation, and monitors changes to applicable regulations. The role works closely with Quality, Product Development, Engineering, Supply Chain, Marketing, and other departments to ensure regulatory requirements are identified and incorporated throughout the product lifecycle.
Responsibilities
Support regulatory compliance activities for medical devices and other regulated products marketed or distributed by Marketlab
Maintain applicable FDA establishment registrations, device listings, and other regulatory records
Support regulatory activities associated with FDA requirements, including device classification, product codes, establishment roles, labeling, registration and listing, and post-market requirements
Maintain applicable Health Canada establishment licenses, medical device licenses, registrations, and supporting regulatory documentation, as applicable
Support compliance with Canadian medical device labeling, licensing, importer/distributor, and establishment requirements
Support compliance with the EU Medical Device Regulation (EU MDR) and applicable European regulatory requirements
Maintain European regulatory information and documentation, including applicable economic operator, EUDAMED, UDI, labeling, and registration requirements
Coordinate with manufacturers, authorized representatives, importers, distributors, and other economic operators to obtain and maintain required regulatory documentation
Determine applicable regulatory requirements for new and existing products based on product type, intended use, claims, classification, and markets where the product will be distributed
Research and document medical device classifications and applicable regulatory pathways
Support regulatory assessments for products outside of medical device regulations, as applicable
Review new products and product changes to determine regulatory impact and identify required regulatory activities before implementation
Participate in new product development and product introduction activities to ensure regulatory requirements are identified early in the process
Review product labeling, packaging, instructions for use, marketing materials, and product claims for compliance with applicable regulatory requirements
Review manufacturer and supplier regulatory documentation, including registrations, licenses, certifications, declarations, and other supporting records
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Support UDI and device identification requirements for applicable markets
Maintain regulatory files and records to ensure documentation is accurate, current, complete, and readily retrievable
Maintain regulatory databases, trackers, licenses, registrations, and renewal schedules
Monitor expiration and renewal dates and ensure required regulatory activities are completed within established timelines
Respond to regulatory documentation requests from customers, suppliers, internal departments, and other business partners
Assist with regulatory questions related to importing and distributing regulated products
Support regulatory due diligence associated with new suppliers, new products, acquisitions, and business opportunities
Monitor changes to FDA, Health Canada, EU, and other applicable regulations and communicate potential business or product impacts to appropriate stakeholders
Perform regulatory impact assessments for new and changing requirements
Support implementation of regulatory changes by working cross-functionally with affected departments
Support regulatory activities related to complaints, recalls, field actions, and other post-market activities as needed
Assist with regulatory authority inspections, customer audits, and Quality Management System audits
Support compliance with ISO 13485 and applicable Quality Management System requirements
Assist with international regulatory activities and registrations outside the United States, Canada, and European Union as business needs require
Serve as a regulatory resource to Product Development, Engineering, Marketing, Supply Chain, Customer Experience, Sales, and other departments
Develop and maintain effective working relationships with suppliers, manufacturers, regulatory representatives, and other external partners
Perform regulatory research and prepare written regulatory assessments, recommendations, and documentation
Escalate significant regulatory risks or compliance concerns to Regulatory and Quality Management
Support regulatory inspections, ISO certification audits, as well as customer audits
Perform miscellaneous regulatory projects as directed by Regulatory and Quality Management
Requirements
Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, Quality, or a related field
Three or more years of Regulatory Affairs experience in the medical device or healthcare industry
Direct experience with U.S. FDA medical device regulations, including experience with device classification, establishment registration, device listing, and labeling requirements
Direct experience with Health Canada medical device regulations, including experience with establishment licensing, medical device licensing, and applicable labeling and distribution requirements
Direct experience with European Union medical device regulations, including practical knowledge of the EU MDR (Regulation (EU) 2017/745), economic operator requirements, labeling, UDI, and applicable registration requirements
Working knowledge of ISO 13485 and medical device Quality Management System requirements
Experience performing regulatory assessments for new products and product changes
Experience reviewing medical device labeling, packaging, instructions for use, and marketing claims for regulatory compliance
Experience maintaining regulatory registrations, licenses, and supporting documentation
Experience researching and interpreting regulations and translating regulatory requirements into practical business requirements
Experience working with manufacturers, suppliers, authorized representatives, importers, or distributors
Experience with international medical device registrations outside the U.S., Canada, and EU is a plus
Experience with UDI requirements and regulatory databases such as FDA FURLS/GUDID and EUDAMED
RAC certification or other Regulatory Affairs certification is a plus
Proficient with Microsoft Office and Google Workspace; experience with ERP, document management, and electronic Quality systems
Strong research, analytical, and problem-solving skills
Strong written and verbal communication skills
Ability to interpret complex regulatory requirements and clearly communicate their impact to non-regulatory personnel
Strong attention to detail and organizational skills
Ability to independently manage multiple regulatory projects, registrations, and deadlines
Ability to work effectively across departments and with external manufacturers and suppliers
Benefits
Paid parental leave
Scholarship reimbursement
401k match
Benefits effective day one of employment
Paid short term disability leave
Generous PTO policy that starts on day one
Paid holidays
Health and wellness program
Employee discount program within our family of companies
About the Company
Marketlab is a market-leading healthcare solutions organization specializing in the design, manufacturing, and sourcing of private label products. Based in Grand Rapids, Michigan, Marketlab's mission is to provide healthcare partners timely solutions with a straightforward approach based on knowing them and their work.
