Senior Associate - Regulatory Affairs (EU MDR)

Responsibilities:

• 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

Minimum Requirements:

• 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