Regulatory Affairs Specialist

Job Description

Job Description

Regulatory Affairs Specialist

Job Description

Who We Are:

Marketlab is a market leading healthcare solutions organization specializing in the design, manufacturing, and sourcing of private label products. It’s our mission to provide our healthcare partners timely solutions with a straightforward approach based on knowing them and their work. Every day we strive to positively impact the lives of the people who in turn impact the health and wellness of our communities. 

Based in Grand Rapids, Michigan, Marketlab’s success is built upon a foundation of collaboration, innovation, and the belief that every team member plays a vital role in creating an exceptional customer service experience.

The Opportunity:

The Regulatory Affairs Specialist is responsible for supporting Marketlab’s regulatory compliance activities for medical devices and other regulated products distributed in the United States, Canada, European Union, and other applicable markets.

This position is responsible for maintaining product and establishment registrations, evaluating regulatory requirements, reviewing product labeling and claims, supporting new product introductions and product changes, maintaining regulatory documentation, and monitoring changes to applicable regulations.

The Regulatory Affairs Specialist 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. This position requires practical experience with U.S. FDA, Health Canada, and European Union medical device regulations.

This role reports to the Quality and Regulatory Manager.

Functional/Technical Competencies

• Regulatory Knowledge – Demonstrates practical knowledge of FDA, Health Canada, and EU medical device regulatory requirements and effectively applies those requirements to products and business activities.
• Regulatory Research and Interpretation – Effectively researches regulations, guidance, and standards and translates requirements into clear and actionable business requirements.
• Risk Assessment – Identifies potential regulatory risks, evaluates their significance, and appropriately escalates compliance concerns.
• Business Acumen – Understands how regulatory requirements affect product development, sourcing, market access, distribution, and business operations.

Behavioral Competencies

• Attention to Detail – Maintains accurate registrations, licenses, product information, labeling, and regulatory documentation.
• Problem Solving – Researches regulatory questions, evaluates available information, and develops practical solutions that support both compliance and business objectives.
• Communication – Clearly communicates regulatory requirements and issues to technical and non-technical stakeholders.
• Organization and Planning – Effectively manages multiple registrations, renewals, regulatory projects, and deadlines.
• Quality of Work – Accepts responsibility for the accuracy, completeness, and timeliness of regulatory work and documentation.
• Teamwork – Collaborates effectively with Quality, Product Development, Engineering, Supply Chain, Marketing, Sales, Customer Experience, and external partners.
• Continuous Learning – Maintains current knowledge of changing regulations and proactively identifies regulatory developments that may impact Marketlab.

What You’ll Do:

• 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 after 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.
• 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.

What You’ll Need

The ideal candidate will have:

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, Quality, or a related field required.
• Three or more years of Regulatory Affairs experience in the medical device or healthcare industry preferred.
• Direct experience with U.S. FDA medical device regulations is required, including experience with device classification, establishment registration, device listing, and labeling requirements.
• Direct experience with Health Canada medical device regulations is required, including experience with establishment licensing, medical device licensing, and applicable labeling and distribution requirements.
• Direct experience with European Union medical device regulations is required, 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 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.
• Proficient with Microsoft Office and Google Workspace; experience with ERP, document management, and electronic Quality systems preferred.
• 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