Medical Device Registration Coordinator

Site Overview:

Young Innovations is a manufacturer and marketer of high-quality dental equipment with sales in excess of $100 million. With an outstanding reputation for quality, the company has a broad portfolio of market leading products across a variety of categories.

CHARACTERISTICS OF THE CLASS: The Medical Device Registration Coordinator responsibilities include the activities associated with producing technical files for the registration of medical device in international markets.

ESSENTIAL DUTIES:

• Navigates complex international requirements to ensure medical devices can be legally marketed and sold in various countries, focusing on compliance, documentation, and regulatory submissions.
• Work with the RA Team to ensure products are compliant in the registered countries.
• Interpret country regulatory requirements to ensure the timely production of registration packages.
• Work with Production and R&D groups in the production of technical records required for production of technical files (for international registrations).
• Address any issues that prevent registrations by working with internal and external partners.
• Produce technical packages required for the new international licenses and registrations.
• Partner with country Market Authorization Holders (MAH) to produce technical submissions that will be accepted by the approving Authorities.
• Work with MAHs to obtain government approval and the registration of products.
• Submit registration packages to international partners. Maintain effective communication with internal and external partners.
• Produce technical packages required for the renewal of active licenses and registrations.
• Maintain active registrations of products and facilities.
• Maintain the databases used to manage international registrations.
• Update and provide high-level reports on the status of the Global Expansion program.

RELATED DUTIES:

• Any additional duties assigned by supervisor and/or manager.

MINIMUM QUALIFICATIONS:

• Excellent skills using MS Office.
• Positive Attitude and ability to manage multiple projects at once.
• Exceptional communication skills.
• Associates degree or above.

Knowledge, Abilities and Skills

• Ability to plan effectively.

PHYSICAL REQUIREMENTS:

• Long periods of sitting and computer work.

Working Conditions

Office environment and occasional exposure to manufacturing plant environment, with some abnormal variations in temperature, unavoidable fumes, noise, dust and atmospheric conditions.

Pay Range:

The pay range reflects the minimum and maximum target for the position at the time of posting. Within the range, the compensation will be determined based on education/training, skill set, experience, and other organizational needs.

Young Innovations, Inc. is an Equal Opportunity Employer and E-Verify participating employer.