Regulatory Affairs Specialist (remote)

Regulatory Affairs Specialist (remote)

We are the industry leader in dental technology due to our agility, speed, and cutting-edge technology. We work in a fast-paced and highly sought-after employee-friendly work environment. Behind all this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. If you share in our passion for teamwork and a vision for excellence, let's talk about a rewarding career!

In addition are the following generous employee benefits: Medical, Dental, Vision, 401K with company match, company-paid life insurance, additional onsite dental services, vacation, holiday, and sick time, employee gym (with fitness classes and meditation room), employee medical/wellness center (with massage therapy and acupuncture), two company subsidized cafes, Internet cafes, employee lounges with big screen TVs, game tables, fun company sponsored events, a diverse work environment with over forty nationalities represented, and much more!

Essential Functions:

• Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies.
• Maintains company registrations and device listings in the US, Canada, EU, and other countries.
• Supports and maintains technical files, MDD certifications, and declarations of conformity in support of EU product registrations/CE mark.
• Maintains knowledge on current regulations and guidelines.
• Evaluates compliance with applicable regulations, project policies, and procedures
• Reviews and writes standard operating procedures (SOPs) and other RA/QA policies as necessary.
• Collaborates with technical staff to foster understanding of SOPs and guidance documentation.
• Coordinates with international regulatory team members regarding product change and regulatory notification and/or approval requirements.
• Serves as subject matter expert for Regulatory Affairs.
• Provides management with ideas for developing and implementing strategies and processes.
• Analyzes advertisements, labels, and public communication documents for regulatory compliance.
• Reports significant regulatory issues related to a product's release to appropriate parties.
• Evaluates product compliance to applicable regulations and project requirements.
• Participates and assists with FDA facility inspection, notified body audits, and other government inspections as needed.
• Performs other related duties and projects as business needs require at the direction of management.

Education and Experience:

• Bachelor's degree in related field preferred.
• Minimum two (2) years of experience in Regulatory Affairs.
• Demonstrated knowledge of FDA 510K and ISO 13485 Standards.

Special Requirements/Certification:

• Certification in regulatory affairs and auditing strongly desired.