Manager Clinical Post Market Compliance

Manager Clinical Post Market Compliance

Requirements

• Bachelor’s Degree or accredited management certification (Regulatory certification preferred)
• 7-9 years in a medical device environment preferred
• 4-6 years of management experience preferred
• Clinical or bedside experience preferred
• Capable of managing people at different levels
• Excellent verbal & written communication skills
• Proficient with FDA QSR, ISO13485, MDD, EU MDR, and ISO14971 for Medical Devices
• Ability to lead discussions and meetings effectively
• Ability to meet objectives, prioritize and execute strategies in a timely manner
• Exceptional organizational skills

Responsibilities

• Management of direct reports
• Maintain compliance with global medical device regulations (EU MDR, FDA, ISO, etc.)
• Manage clinical and post-market documents (CERs, PMS/PMCF reports, SSCPs, PSURs)
• Monitor regulatory changes and update procedures accordingly
• Support clinical affairs and risk management by aligning with regulations
• Assess clinical risks and coordinate recalls with PMSR teams
• Assist with regulatory submissions and agency communications
• Develop strategies for clinical and post-market compliance and collaboration
• Provide clinical inputs to post-market surveillance and adverse event reporting
• Analyze clinical data and safety signals to improve product safety
• Collaborate with internal teams (Regulatory, Quality, R&D, Medical Affairs)
• Stay updated on regulatory trends and industry best practices
• Optimize processes for efficiency in evaluations and documentation
• Work on regulatory data management systems

Preferred Qualifications

• Regulatory certification preferred
• 7-9 years in a medical device environment preferred
• 4-6 years of management experience preferred
• Clinical or bedside experience preferred