Job Description

Regulatory Affairs Specialist

Overview:

Our client is seeking a skilled Regulatory Affairs Specialist to support the planning, coordination, and execution of regulatory strategies for medical products requiring government approval. This role is ideal for a detail-oriented individual with in-depth regulatory knowledge and proven experience preparing submissions of basic to medium complexity.

Key Responsibilities:

• Develop and implement regulatory strategies to support product submissions and approvals
• Prepare, review, and submit regulatory documentation in accordance with applicable regulations and guidelines
• Interpret and apply relevant healthcare regulations and statutes to ensure compliance
• Translate complex technical data into clear, concise, reviewer-friendly content
• Collaborate with cross-functional teams to refine and validate submission data
• Serve as a liaison with regulatory authorities to support product clearance or approval processes
• Ensure submissions meet all applicable regulatory requirements and internal quality standards
• Contribute to the strategic direction of regulatory pathway development for assigned products
• Act as a resource and mentor for junior regulatory colleagues

Qualifications:

• Bachelor’s degree in life sciences, engineering, or a related field (advanced degree preferred)
• 5+ years of experience in Regulatory Affairs within the medical device, diagnostics, or healthcare industry
• Strong working knowledge of FDA, EU MDR/IVDR, and other international regulatory requirements
• Demonstrated success in preparing and managing regulatory submissions
• Experience interacting with regulatory bodies (e.g., FDA, Notified Bodies)
• Familiarity with submission types such as 510(k), PMA, CE Mark, Technical Documentation
• Understanding of competitive products and evolving regulatory landscapes

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