Sr. Specialist, Regulatory Affairs- Medical Device

Position Summary

Under the supervision of the Regional Director, Regulatory Affairs, this role supports the preparation of regulatory 510(k) submissions, Health Canada licenses, and assists 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

• 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).
• 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.
• 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.
• Develop the US, Canadian, and LATAM regulatory strategy, collaborating with appropriate functional partners and contributing 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.
• 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.
• Prepare responses to health authority questions and other regulatory correspondence.
• Ensure 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.

Education & Experience

• 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 Affairs Certification is highly desirable.

Skills

• 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.

Abilities

• 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.

What Makes Sunstar Special

• A business focused on health and wellness of people around the world.
• High Quality Products.
• Beautifully state-of-the-art facility.
• Diversity and Inclusion Corporate Social Responsibility Program and partnership with charitable organizations.
• Strong value placed on company culture.
• 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.

Pay Range

The pay range for this position of Regulatory Affairs Specialist is $83,204- $124,806. However, base pay offered may vary depending on skills, experience, job-related knowledge and location. This position is also eligible for an annual bonus as part of total compensation.