Associate, Regulatory Affairs (Medical Devices)

Nice to have:

•    Minimum 1 year of experience in Regulatory Affairs within the medical device industry (regulatory registrations/ submissions preferred)

•    General knowledge of EU MDD/MDR, US FDA QSR, and ISO 13485 standards

•    Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint

•    Manage, plan, prepare, and deliver both electronic and paper-based documents to support global regulatory registrations, renewals, tenders, customs, and related activities

•    Coordinate the preparation and submission of medical device applications by providing timely and accurate regulatory information and documents, and follow-up closely on queries from inspection through approval

•    Evaluate documents for accuracy, appropriateness, and consistency for various regulatory submissions

•    Prepare and/or review letters of authorization, cover letters for registration certificates, declarations, powers of attorney, and other regulatory documents

•    Perform and/or coordinate legalization, notarization, and apostille of regulatory documents as required

•    Ensure compliance with current good documentation practices including but not limited to proof reading, formatting, indexing, record keeping, etc.

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 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.

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