Role Overview We are looking for a strong Regulatory Affairs Manager who is a self-motivated, highly confident, and results-oriented professional to join the Young Innovations, team at our Algonquin, IL location. The Regulatory Affairs Manager will be responsible for supporting corporate-wide global initiatives to establish and maintain submission plans and associated timelines, and represent Young Innovations operations from a Regulatory perspective.
Direct the coordination of corporate-wide Regulatory Affairs activities for Medical Devices and Drugs.
Develop and execute regulatory plans for projects, including new products and maintenance of licenses/authorizations for existing products.
Manage successful submissions for new marketing authorizations, renewals, variations and line extensions for the USA and International regions (LATAM, MEA, APAC, CIS) and drive the approval process.
Manage domestic and international registrations, listings, ISO certifications, and in-country product registrations.
Monitor applicable regulatory requirements; assure compliance with Young Innovations’ internal requirements and external standards.
Create technical files and clinical evaluation reports for products distributed in Europe.
Ensure that changes are documented in accordance with internal procedures and are communicated in a timely manner to the Health Authorities.
Represent the RA function on assigned cross-functional project teams.
Establish appropriate communication within other functions primarily at project level.
Ensure project teams, business objectives, and deliverables are aligned with regulatory strategy.
Perform gap analysis and propose solutions to maintain compliance to internal and external regulatory requirements.
Develop and document sound regulatory decisions and justifications.
Review promotional material or SOPs for compliance with local and global regulations.
A Bachelor of Science degree in a related field, supplemented by at least 7 years of relevant experience with 2 years in a leadership role with a demonstrated pattern of success
Strong knowledge of Regulatory as it relates to Medical Devices and Drugs
Excellent Technical and Clinical writing skills and ability to conduct Clinical Research using medical literature and online tools.
Ability to manage complex projects and timelines in a matrix team environment
Strong oral and written communication skills and presentation skills
Ability to independently identify compliance risks and escalate when necessary
Internal Number: 1
About Young Dental
Young Innovations develops, manufactures and markets supplies and equipment used by dentists, hygienists, dental assistants and consumers. Our portfolio of brands includes products that hold leadership positions in the preventive, restorative, orthodontic, endodontic and diagnostic segments.