Senior Staff Specialist, Regulatory Affairs
Compliance / Regulatory
Remote
About the Role We are seeking a highly skilled Senior Staff Specialist in Regulatory Affairs to support regulatory activities associated with a Legal Manufacturer address change. This role will work cross‑functionally to ensure all required regulatory updates are completed accurately, efficiently, and in compliance with global regulatory requirements.
Responsibilities
Lead regulatory actions required to support a Legal Manufacturer address change across global markets.
Update and maintain regulatory documentation, including technical files, declarations, labeling, and product registrations.
Assess regulatory impact across product portfolios and ensure timely execution of required submissions.
Coordinate with Quality, Regulatory, Labeling, and cross‑functional partners to ensure alignment and compliance.
Prepare and submit regulatory notifications, variations, and updates to health authorities as required.
Ensure all documentation meets applicable regulatory standards and internal quality system requirements.
Track progress, maintain documentation logs, and provide regular status updates to stakeholders.
Qualifications
Bachelor’s degree in a scientific, engineering, or regulatory discipline (advanced degree preferred).
5+ years of experience in Regulatory Affairs within the medical device or related regulated industry.
Strong understanding of FDA, EU MDR, and global regulatory requirements.
Experience with regulatory submissions, labeling updates, and change management.
Excellent communication, documentation, and cross‑functional collaboration skills.
Ability to work independently in a remote environment and manage multiple priorities.