Specialist, Regulatory Affairs- Medical Device

Sunstar•Schaumburg, IL

1d•Hybrid

About The Position

At Sunstar Americas, Inc., we firmly believe that our people are the foundation of our success. We foster a collaborative, innovative, and agile culture that ensures we deliver high-quality, innovative products to consumers and oral care professionals. Our team-oriented approach encourages creative thinking and nurtures a positive work environment and productive relationships. With dedication, hard work, and a shared vision, we can continue to make SAI a leader in our industry. Join us and become part of our global team, where together, we can achieve success and contribute to a better future. 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. Essential Job Functions: 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. Other Duties: 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

Requirements

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.
Working knowledge of US FDA and Health Canada Regulatory Authority computerized submission systems
Excellent written and verbal communication skills
Proficiency in MS Office applications including Word, Excel, PowerPoint including creation of graphs
Good interpersonal and organizational skills
Ability to read, interpret and appropriately apply regulations and guidance to support regulatory submission in US, Canada and LATAM regions.
Ability to set and meet goals and perform job responsibilities under supervision of the Regional Director, Regulatory Affairs.

Nice To Haves

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 Affairs Certification is highly desirable.
Experience with regulations for Medical Device Software in US.

Responsibilities

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.

Benefits

Excellent, comprehensive insurance coverage that includes Medical, Vision, and Dental benefits.
Opportunities for career growth and advancement
Employee discount on Sunstar products
401K retirement plan with employer match (Pretax and Roth options)
401K profit sharing contribution based on company performance.
Paid holidays and generous paid time off.
Pet, Legal and Identity Theft Insurance Plans
Competitive bonus
On-site café
On Site Fitness Center
Corporate Perks Discount Program (Auto, Retail, Electronics, Entertainment, Computers, Personal Vacations, Cell Phones, Movie Tickets, Eating Out and Much More)
Holiday Lunches
Beautifully maintained walking trails
Hybrid Schedule (certain departments)
Numerous employee appreciation events throughout the year.
Recognition and Rewards Programs
Anniversary, Birthday and New Hire Announcements