Job Description
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a Regulatory Affairs Associate (HYBRID) on a permanent basis at Raritan, NJ .
Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!
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.
The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-PR1 #Hybrid
Job Tags
Permanent employment, Full time, Internship, Work at office, Worldwide,