Senior 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!

Senior Regulatory Affairs Specialist responsibilities:

• Prepare and submit product registrations and submissions (510k's) to FDA and other regulatory bodies.
• Maintains company registrations and device listings in the US, Canada, and the EU.
• Analyzes and reports department metrics.
• Supports and maintains technical files, MDD certifications, and declarations of conformity in support of EU product registrations/CE mark.
• Informs coordinator of product recalls.
• Performs and supports internal, external, and third-party audits.
• 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.
• Composes audit plans and reports.
• Conducts audits and inspections of GMP and non-regulated documentation.
• Tracks internal and external corrective and preventive actions.
• Performs other related duties and projects as business needs require at direction of management.

Education and Experience:

• Bachelor's degree in related field preferred.
• Minimum 4+ years of experience in Regulatory Affairs.
• Demonstrated knowledge of FDA 510K and ISO 13485 Standards.
• Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Manufacturing Practice, Good Practices training programs, SOP development, and GMP audits and inspections).
• Must possess effective oral communication and interpersonal skills with ability to deal with all levels of personnel in a professional and effective manner.
• Ability to analyze and collate data for presentations and reports.
• Ability to interpret and collate data to present an accurate picture of market potential.

• Certification in regulatory affairs and auditing strongly desired.