Specialist, Regulatory Affairs

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.

Why Work at Sunstar? Sunstar’s mission is to enhance the health and well-being of people everywhere via its four business areas: mouth and body, health and beauty, healthy home, safety and technology.

Position Summary:

Under the supervision of the Director, Regulatory Affairs, this role is responsible for supporting the preparation of regulatory 510(k) submissions and assisting international business partners in Latin America, Asia and Europe with product registrations; preparation of technical files; provide change notifications to foreign distributors and notified bodies; provides regulatory support to lifecycle management and new product development/new product introduction, Unique Device Identifier GUDID maintenance, on market labeling and submission impact reviews and international product registrations 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 . 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 LATAM region for a broad product portfolio including medical devices, consumer packaged goods, drugs 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 LATAM regulatory strategy collaborating with appropriate functional partners and contribute to business strategy.
• Support and make recommendations for projects by working closely with LATAM functional partners and Manager Regulatory Affairs 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 and international regulations and standards
• Oversee MDR and complaints; submit adverse events to the US FDA and assess impact to other markets.
• Ensure preparation of 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 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.

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 our without notice

Education

BS in Science or Medical / Healthcare related field or higher

Knowledge/Experience

• Minimum of 3 years of related regulatory and/or Quality experience in US regulated Medical Devices industry with Class I and II Medical Devices and combination products.
• Authoring 510(k) submissions in US FDA electronic system – highly desirable.
• Direct experience with international medical device/cosmetic/drug registration (especially Brazil, Colombia, Argentina, Mexico, Canada 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 highly desirable.

Skills

• Working knowledge of Regulatory Authority computerized submission systems in ESG portal
• Excellent written and verbal communication skills
• Proficiency in MS Office applications including Word, Excel, PowerPoint
• Good interpersonal and organizational skills

Abilities

• Ability to read, interpret and appropriately apply regulations and guidance to support regulatory submission in US, Europe, Canada and LATAM regions. Ability to set and meet goals and perform job responsibilities under supervision of Director, Regulatory Affairs.

Travel

• Some domestic or international travel may be required.
• Ability to travel and drive a car to attend meetings and seminars

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)