Regulatory Affairs Specialist – Labeling and Operations

Regulatory Affairs Specialist – Labeling and Operations

Requirements

• Bachelor’s degree in Physical or Life Sciences; or a High School Diploma/ General Education Degree (GED) and 4 years of relevant career experience in lieu of Bachelor’s degree.
• 2+ years relevant experience in a regulated pharmaceutical or medical device environment.
• Basic computer skills to include Internet navigation, Email usage, and word processing.
• Proficient in Microsoft Office.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Responsibilities

• Participate or support the preparation and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution approvals and/or clearances.
• Represent Regulatory Affairs on various project teams by attending team meetings and providing the required plans, procedures and regulatory decisions.
• Confer with other Regulatory Affairs subject matter experts about the regulatory requirements of new product designs and/or changes to existing designs.
• Support development, review, and approval of labeling content and packaging, including Instructions for Use (IFUs), cartons, and labels in accordance with global regulatory requirements.
• Coordinate cross-functional reviews of labeling content and ensure timely implementation of labeling updates.
• Maintain labeling change control documentation, systems, and records.
• Support regulatory operations functions, including document formatting, tracking, and submission readiness across systems and regulatory platforms.
• Manage regulatory archives consistent with regulatory and quality policies.
• Assist with publishing documents for global submissions using electronic submission tools (e.g., eSTAR, ESG).
• Maintain data integrity in regulatory systems including registration tracking tools and document repositories.
• Collaborate with cross-functional teams and stakeholders to ensure accuracy and consistency of regulated content and documentation.
• Stay current on global regulatory requirements related to labeling and operations and apply learnings to improve internal procedures.
• Support and comply with the company’s Quality Management System policies and procedures.
• Review and approve product labeling and marketing material. Initiate new package inserts and other required product labeling.
• Demonstrate continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including FDA regulations and policies applying to medical devices including, PMAs, 510(k)s, labeling and promotional materials, global registration, and technical writing.

Preferred Qualifications

• Experience with labeling content development or change control documentation.
• Familiarity with regulatory systems and tools.
• Knowledge of UDI requirements, GUDID submissions, and global labeling regulations.
• Experience with electronic submissions or technical formatting for regulatory documents.