MDR Marketing Expert / Medical Device Claims Analyst

Location: Massachusetts
Duration: Long Term

About the role

We are seeking an experienced MDR Marketing Expert / Medical Device Claims Analyst to support regulatory affairs and medical device claims management activities. The ideal candidate will review and substantiate product claims, analyze technical documentation, manage claims data, and collaborate with cross-functional teams to ensure compliance with regulatory and quality requirements.

Responsibilities

• Review and categorize medical device claims according to established regulatory guidelines.
• Analyze technical documentation and data to support product claims and regulatory submissions.
• Perform data mining of evidence documents from Windchill, Agile PLM, and related systems.
• Review claims language and substantiation with Subject Matter Experts (SMEs).
• Maintain accurate claims databases, spreadsheets, and supporting documentation.
• Support the development and maintenance of claims procedures and work instructions.
• Route claims documentation and manage document workflows within PLM systems.
• Collaborate with Regulatory Affairs, Quality, Marketing, and Engineering teams to resolve claims-related questions.
• Ensure claims documentation complies with company and regulatory requirements.
• Support global claims management activities across multiple regions.

Requirements

• 4–7 years of experience in Regulatory Affairs, Medical Device Claims, Technical Documentation, or a related field.
• Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or a related discipline.
• Experience working in the medical device industry.
• Hands-on experience with Windchill, Agile PLM, or similar document management systems.
• Knowledge of medical device regulations, product claims, and technical documentation.
• Strong analytical, documentation, and data management skills.
• Experience working with cross-functional teams and Subject Matter Experts (SMEs).
• Excellent communication, organizational, and problem-solving skills.