[Remote] Senior Associate, Regulatory Affairs Consultant (Medical Devices)

🌍 Remote, USA 🎯 Full-time 🕐 Posted Recently

Job Description

Note: The job is a remote job and is open to candidates in USA. ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They are seeking a Senior Associate, Regulatory Affairs Consultant with a focus on EU MDR to collaborate with clients' regulatory project teams and ensure compliance with necessary documentation and regulatory requirements.

Actively collaborate with the client’s regulatory project team to identify and collect all necessary TF/DD documents in compliance with EU MDR (2017/745) and related guidance (MDCGs) for maintenance and resubmission. The high-level activities may include but are not limited to:
Identify applicable regulatory requirements, harmonized standards, guidance documents, and submission expectations
Review, obtain, and combine TF/DD documents in PLM or similar regulatory sources into Adobe PDF files
Create and upload bookmarks/indexes of the Adobe PDF files into PLM via Change Orders
Perform Quality Control checks in accordance with client procedures, training, and checklists, including verification of completeness, correct pagination, and absence of blank or missing pages
Work with cross-functional teams and affiliates to obtain necessary legal documents (e.g., Certificate to Foreign Government (CFG), Certificate of Free Sale (CFS), and/or supporting documents from projects)
Respond to inquiries from the Company’s local affiliates and proactively notify and coordinate with cross-functional teams including management any health authority–related questions or requests
Represent Regulatory Affairs on project teams and report regulatory requirements in the frequency, format, and sequence as required
Attend meetings and communicate with the project team as appropriate
Routinely communicate with regulatory management team regarding project status and deliverables
Support other regulatory activities as assigned

Bachelor's degree (life sciences preferred)
Minimum of 1 year of working experience in Regulatory Affairs focused on EU MDR
Knowledge of EU MDR, ISO13485, and FDA Medical Device regulations is mandatory
Working proficiency in Microsoft Office (e.g., Word, Excel, PowerPoint)
Strong written and verbal English communication skills required

ClinChoice is a Reaserch and Deveiopment platform that develops innovative drugs and devices. It was founded in 1995, and is headquartered in Shanghai, Shanghai, CHN, with a workforce of 1001-5000 employees. Its website is https://www.clinchoice.com.cn.

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