Senior Regulatory Compliance Specialist Medical Device

Responsibilities

• Provide quality system support through conformity assessment procedures, technical documentation preparation, medical device file development and maintenance, risk management, and post-market surveillance for medical device market access.
• Coordinate and assist with both internal and external audits, including Notified Body audits related to CE marking, and help manage corrective and preventive actions (CAPA).
• Assist with monitor compliance with changing European regulatory requirements and act as a subject matter expert on EU market authorization.
• Maintain up-to-date knowledge relevant regulations, work collaboratively with cross-functional teams to meet quality objectives, analyze HQMS data and metrics for management reporting, and support supplier quality management activities.

Qualifications

• 5 plus years of relevant experience
• BA/BS or advanced degree preferred
• Understanding of quality management system standards and risk management
• Excellent written and verbal communication skills
• Project Management Skills
• Ability to adjust and adapt to changing priorities in a dynamic environment.