Regulatory Affairs Specialist

Crecera Brands•Caledonia, MI

About The Position

The Regulatory Affairs Specialist supports Marketlab’s regulatory compliance activities for medical devices and other regulated products distributed in the United States, Canada, the European Union, and other applicable markets. The role 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 regulatory changes. Working with Quality, Product Development, Engineering, Supply Chain, Marketing, and other departments, the Specialist helps identify and incorporate regulatory requirements throughout the product lifecycle. The position requires practical experience with U.S. FDA, Health Canada, and European Union medical device regulations and reports to the Quality and Regulatory Manager.

Requirements

Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, Quality, or a related field required.
Direct experience with U.S. FDA medical device regulations, including device classification, establishment registration, device listing, and labeling requirements.
Direct experience with Health Canada medical device regulations, including establishment licensing, medical device licensing, and applicable labeling and distribution requirements.
Direct experience with European Union medical device regulations, including practical knowledge of 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.
Proficiency with Microsoft Office and Google Workspace.
Strong research, analytical, and problem-solving skills.
Strong written and verbal communication skills, including the ability to explain complex regulatory requirements 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.

Nice To Haves

Three or more years of Regulatory Affairs experience in the medical device or healthcare industry preferred.
Experience working with manufacturers, suppliers, authorized representatives, importers, or distributors preferred.
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 preferred.
RAC certification or other Regulatory Affairs certification is a plus.
Experience with ERP, document management, and electronic Quality systems preferred.

Responsibilities

Support regulatory compliance activities for medical devices and other regulated products marketed or distributed by Marketlab.
Maintain applicable FDA establishment registrations, device listings, regulatory records, Health Canada licenses and registrations, and European regulatory information and documentation.
Support compliance with FDA, Health Canada, EU MDR, and other applicable regulatory requirements, including labeling, licensing, registration, listing, UDI, importer/distributor, and post-market requirements.
Coordinate with manufacturers, authorized representatives, importers, distributors, and other economic operators to obtain and maintain required regulatory documentation.
Determine regulatory requirements for new and existing products based on product type, intended use, claims, classification, and distribution markets; research and document classifications and regulatory pathways.
Support regulatory assessments for products outside medical device regulations, as applicable.
Review new products and product changes for regulatory impact and identify activities required before implementation; participate in new product development and introduction.
Review product labeling, packaging, instructions for use, marketing materials, and product claims for regulatory compliance.
Review manufacturer and supplier registrations, licenses, certifications, declarations, and other regulatory documentation.
Maintain accurate, current, complete, and retrievable regulatory files, databases, trackers, licenses, registrations, and renewal schedules; monitor expiration dates and complete renewals on time.
Respond to regulatory documentation requests and assist with regulatory questions concerning importing and distributing regulated products.
Support regulatory due diligence for new suppliers, products, acquisitions, and business opportunities.
Monitor regulatory changes, conduct impact assessments, communicate potential impacts, and support implementation across affected departments.
Support 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 QMS 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 internal departments and maintain effective relationships with suppliers, manufacturers, regulatory representatives, and other external partners.
Conduct regulatory research and prepare written assessments, recommendations, and documentation; escalate significant regulatory risks or compliance concerns.
Perform miscellaneous regulatory projects as directed by Regulatory and Quality Management.