Regulatory Affairs Manager

Young Innovations•,

3d•$105,000 - $115,000•Remote

About The Position

The Regulatory Affairs Manager executes assigned regulatory affairs activities under the direction of the Senior Regulatory Affairs Manager. The role supports company-wide global initiatives to establish and maintain licensing and registrations, submission plans, and associated timelines, and represents Young Innovations operations. The position is recognized as a discipline expert and resource in regulatory affairs operations, with regulatory involvement across different product categories and markets. The role coordinates and executes regulatory activities for medical devices, drugs, natural health products (NHPs), and tissue. It develops and executes regulatory plans for projects, including new products and maintenance of existing marketing authorizations. The manager contributes to submissions for new authorizations, renewals, variations, and line extensions in the United States and international regions, and helps drive approvals. The position manages domestic and international registrations, listings, ISO certifications, and in-country product registrations; prepares technical and post-market documentation; supports communication with Notified Bodies and Authorized Representatives; and monitors compliance with internal requirements and external regulations and standards. The manager works with Regulatory Affairs colleagues and cross-functional teams, including Labeling, Product Development/Engineering, Quality Assurance, and commercial teams. The role is fully remote, with travel possibly required to assist with audits or inspections at company locations.

Requirements

Bachelor of Science degree in a related field.
At least three years of relevant experience in Regulatory Affairs.
Sound knowledge of domestic and international regulatory affairs.
Ability to manage complex projects and timelines in a matrix team environment.
Excellent technical and clinical writing skills.
Strong oral and written communication and presentation skills.
Ability to independently identify compliance risks and escalate them when necessary.
Ability to maintain a reliable internet connection and a productive, distraction-free remote work environment.
Consistent availability during established business hours; self-motivation, organization, and accountability.

Responsibilities

Coordinate and/or execute assigned regulatory affairs activities for medical devices, drugs, NHPs, and tissue.
Develop and execute regulatory plans for projects, including new products and maintenance of licenses and authorizations for existing marketing authorizations.
Contribute to submissions for new marketing authorizations, renewals, variations, and line extensions for the United States and international regions, and drive the approval process.
Prepare reports for management as requested.
Manage domestic and international registrations, listings, ISO certifications, and in-country product registrations, including FDA, Health Canada, Eudamed, and global registrations.
Create technical documentation, Clinical Evaluation Reports, and post-market reports for products distributed in the EU and UK.
Coordinate communications about changes or audit responses with Notified Bodies and Authorized Representatives.
Ensure changes are documented under internal procedures and communicated promptly to applicable authorities.
Monitor applicable regulatory requirements and assure compliance with internal requirements and external standards.
Perform gap analyses and propose solutions to maintain compliance with regulations and standards, including ISO and IEC requirements.
Develop and document regulatory decisions and justifications.
Review and approve product labeling.
Review promotional materials or QMS SOPs for compliance with local and global regulations.
Represent the Regulatory Affairs Department in project meetings and cross-functional teams.
Coordinate with Labeling, Product Development/Engineering, Quality Assurance, and commercial teams.
Travel, if required, to assist with audits or inspections at company locations.
May directly supervise individuals.