[Hiring] Regulatory Affairs Manager @Young Innovations

Role Description

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.

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.
  • 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.

Qualifications

• A Bachelor of Science degree in a related field, supplemented by at least three years of relevant experience in Regulatory Affairs.
• Sound basis of Domestic and International Regulatory knowledge.
• Ability to manage complex projects and timelines in a matrix team environment.

Requirements

• Excellent Technical and Clinical writing skills.
• Strong oral and written communication and presentation skills.
• Ability to independently identify compliance risks and escalate when necessary.
• Travel may be required to assist with audits or inspections at various company locations.

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.

Company Description

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.