Regulatory Affairs Specialist- Medical Devices

Position Summary

Under the supervision of the Regional Director, Regulatory Affairs, this role is responsible for supporting the preparation of regulatory 510(k) submissions, Health Canada licenses and assisting international business partners in Latin America, Asia, and Europe with product registrations; preparation of technical files; provide change notifications and registration support to foreign distributors and notified bodies; provide regulatory support to lifecycle management and new product development/new product introduction, Unique Device Identifier GUDID maintenance, on market labeling and submission impact reviews, labeling reviews and adverse event reporting;
Yearly Registration of US FDA Establishment License and updates to product listings;
Export documentation to support shipping.

• Under supervision, coordinate, compile, and submit regulatory applications to competent authorities, notified bodies, regulatory agencies, and international business partners, including the preparation of key market international documents, including technical files and 510(k)’s.
• Work with Director, Regulatory Affairs to ensure rapid and timely approval of new products and continued regulatory support of products marketed within and outside the United States, including labeling guidance and adequate deliverables required for technical file and US FDA requirements
• Work to support and ensure regulatory compliance across Canada and LATAM region for a broad product portfolio including medical devices, consumer packaged goods, and cosmetics. This includes creation of US FDA Certificates of Foreign Government, legalization of documents and working with cross functional groups to gather technical data.
• Assist with the development of the US, Canadian and LATAM regulatory strategy collaborating with appropriate functional partners and contribute to business strategy.
• Support and make recommendations for projects by working closely with Canadian and LATAM functional partners to move projects from discovery to launch.
• Under supervision, evaluate proposed product modifications for domestic and international regulatory impact, completing regulatory assessments as needed in change control process.
• Ensure compliance with applicable US, Canadian, Brazilian, Colombian, Mexican and Argentinian regulations and standards
• Oversee MDR and complaints; submit adverse events to the US FDA and assess impact on other markets.
• Prepare necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
• Under supervision, prepare responses to health authority questions and other regulatory correspondence.
• Ensuring the maintenance of Regulatory related policies and procedures in quality management system.
• Update and maintain US FDA Establishment Registration and Listing, Health Canada licenses and the GUDID database for Unique Device Identifiers as products are added and discontinued.
• Provide support to inspections/audits by government agencies and the notified body by producing requested documents or answering any inquiries for information.
• Review and approve promotional materials and labeling for impact to product classification and 510(k)’s and other licenses impacted.

• This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice

BS in Science or Medical / Healthcare related field or higher

• Minimum of 3 years of related regulatory and Quality experience in US and Canada regulated Medical Devices industry with Class I and II Medical Devices and combination products.
• Authored at least one 510(k) submission in US FDA electronic system. Health Canada licensing experience, highly desirable.
• Direct experience with international medical device/cosmetic/drug registration (especially Brazil, Colombia, Argentina, Mexico, and Europe) including export documentation management is desired
• Experience with GUDID/UDI and reporting Adverse Events to the US FDA is desired
• Regulatory…