Global Regulatory Affairs Associate - Medical Devices

Regulatory Affairs Coordinator – International Registrations (Medical Devices) – ClinChoice, Raritan, NJ. Position Summary We are seeking an entry‑level Regulatory Affairs Coordinator to support the international registration of our medical devices. This role focuses on tracking, organizing, and coordinating documentation to ensure timely product approvals worldwide. The Coordinator will work closely with regulatory colleagues and international affiliates to support submission activities, but will not be responsible for authoring regulatory submissions. Key Responsibilities Maintain and update registration tracking databases and logs for international markets. Collect, organize, and prepare supporting documentation for global registration filings. Coordinate with regional affiliates, distributors, and internal teams to gather required information. Review documents for completeness, formatting, and consistency before submission. Assist with document legalization, and notarization processes. Support regulatory team with archiving, filing, and document control. Prepare standard regulatory letters, certificates, and reference documents as needed. Qualifications Bachelor's degree in a scientific, engineering, or related discipline, or equivalent experience. Strong organizational skills with attention to detail. Excellent written and verbal communication skills. Ability to manage multiple projects and deadlines. Interest in learning about regulatory affairs in the medical device industry. Proficiency in Microsoft Office (Word, Excel, Outlook). Preferred Skills & Attributes Strong interest in regulatory affairs and compliance, with a desire to learn and grow in an entry‑level role. Experience with administrative coordination, project support, or documentation management (e.g., internships, co‑ops, or office‑based roles). Ability to track and follow up on tasks and timelines with accuracy. Comfort working with document management systems or databases. Strong problem‑solving skills and willingness to ask questions when unsure. Ability to collaborate across teams and communicate clearly with international colleagues. Multilingual skills or prior experience working with global teams a plus, but not required. ClinChoice is an equal opportunity employer. #J-18808-Ljbffr ClinChoice