Regulatory Affairs Manager (41161)

Company Summary:

At Young Innovations, we foster a dynamic environment where team members make an impact every day as part of a collaborative, inclusive culture. Together, we serve the dental profession and their patients, united in our mission of achieving a Lifetime of Oral Health™

We embrace diverse perspectives and encourage bold thinking, challenging traditional approaches with a bias for action. Whether you’re looking to expand your skills or grow your career, Young is here to support your goals and continuous learning. At Young, YOU are at the core of what we do.

Position Overview:

Under direction from the Sr. RA Manager, execute assigned Regulatory Affairs tasks. This role supports corporate-wide global initiatives to establish and maintain company licensing and registration, submission plans and associated timelines, and represent Young Innovations operations. The Individual is recognized as a discipline expert and resource in regulatory affairs operations.

You’ll like this role if:

• You’re looking for the opportunity to thrive in a fast paced environment with regulatory involvement across different product categories and markets.

Why You’ll Love Working Here:

• Medium sized company – not too big, not too small – just enough to get things done and see your impact.
• Did we say benefits? Full medical, dental, vision, 401k, parental leave, paid holidays, paid time off, short & long term disability insurance, employee assistance program, and more!
• Build on regulatory knowledge of global markets   

Who you’ll work with:

• Reporting to Senior Regulatory Affairs Manager and actively coordinating with other Regulatory Department team members
• Representing the Regulatory Affairs Department in project meetings and cross functional teams
• Coordinating with Departments including Labeling, Product Development/Engineering, Quality Assurance, and commercial teams

What You’ll Do:

• Regulatory Projects
  • Coordination and/or execute assigned RA activities for Medical Devices, Drugs, NHPs, and Tissue.
  • Develop and execute regulatory plans for projects, including new products and maintenance of licenses/authorizations for existing marketing authorizations.
  • Evaluate and communicate regulatory impact of 
  • Contribute to 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.
  • Prepares all reports for management as requested.
• Regulatory Submissions
  • Manage domestic and international registrations, listings, ISO certifications, and in-country product registrations (FDA, Health Canada, Eudamed, global)
  • Creation of Technical Documentation, Clinical Evaluation Reports, and Post-Market Reports for products distributed in the EU and UK
  • Coordinate communication of changes or responses to audits with Notified Bodies and Authorized Representatives
  • Ensure that changes are documented in accordance with internal procedures and are communicated in a timely manner to applicable authorities
• Regulatory Oversight
  • Monitor applicable regulatory requirements; assure compliance with Young Innovations’ internal requirements and external standards
  • Perform gap analysis and propose solutions to maintain compliance to internal and external regulatory requirements such as regulations and standards (ISO, IEC). Develop and document sound regulatory decisions and justifications
  • Review and approve product labeling
  • Review promotional material or QMS SOPs for compliance with local and global regulations
  • May provide direct supervision of individuals