Lead - 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 8-10 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