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Regulatory Affairs Associate – International Registrations (Medical Devices)

Raritan, New Jersey, United States

Location: Raritan, NJ (HYBRID)

Schedule: Permanent- FTE

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 – International Registrations (Medical Devices) in HYBRID model at Raritan, NJ on a permanent basis, while working on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device, and consumer health companies.

 

We are seeking a Regulatory Affairs Associate with 1–3 years of experience to support the coordination and execution of international medical device registrations. This role involves tracking global registration activities, preparing documentation packages, and supporting interactions with regulatory authorities and affiliates. The Associate will contribute to submission preparation but will not serve as the primary author for regulatory strategies or complex filings.

Key Responsibilities
•    Maintain registration databases, trackers, and filing systems for international markets.
•    Prepare and assemble documentation packages for global product registrations and renewals.
•    Support communication with regulatory authorities, distributors, and affiliates to ensure timely submissions.
•    Assist in preparing regulatory certificates, declarations, and reference documents.
•    Review and compile technical documents for completeness, accuracy, and compliance with international requirements.
•    Participate in process improvements related to registration tracking, documentation, and regulatory operations.
•    Provide support during audits or inspections related to registration files.

Qualifications
•    Bachelor’s degree in a scientific, engineering, or related discipline.
•    1–3 years of experience in regulatory affairs, quality assurance, or related documentation/coordination roles within the medical device, pharmaceutical, or healthcare industry.
•    Strong organizational skills with the ability to manage multiple projects and priorities.
•    Familiarity with international registration processes, regulatory documentation, or product dossiers.
•    Excellent written and verbal communication skills.
•    Proficiency with Microsoft Office (Word, Excel, Outlook); experience with regulatory or document management systems a plus.

Preferred Skills & Attributes
•    Demonstrated ability to coordinate regulatory submissions or registration processes with limited supervision.
•    Detail-oriented with strong follow-up and problem-solving skills.
•    Experience working cross-functionally or with global teams.
•    Interest in growing into a regulatory submissions or strategy-focused role over time

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. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

 

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 to 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.

 

Key words: Regulatory Affairs, medical devices, EU MDR, product registrations. 

#LI-PR1 #LI-Hybrid

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