Specialist II Post Market Surveillance (United States)

Responsibilities

• Evaluate, classify, and perform follow-up activities on all Product Complaints.
• Determine if events reasonably suggest a device may have or could have caused or contributed to a death or serious injury, and report accordingly to Government Agencies.
• Resolve complex issues independently within the QA function.
• Prioritize work to meet deadlines.
• Suggest and implement tactical direction for functional areas.
• Investigate and process product complaints while maintaining compliance to all regulations.
• Investigate and document field clinical events and follow-up with Sales Representatives.
• Accountable for compliance with FDA, EU MDD, and other regulations governing adverse event reports such as MDR, MDV, and other reports.
• Evaluates Product complaints for MDR/MDV/Other regulatory agencies as applicable.
• Participates actively during internal and external audits.
• Devises new approaches to problems encountered.
• Documents technical operating procedures for system training and user certification.
• Plans and implements short-term and long-term projects.
• Audits Coordinators’ and Analysts’ work to ensure compliance to departmental procedures and all applicable government regulations.
• Documents audit results in written audit reports that are distributed and reviewed by department management.
• Assists with review of analysis reports and preparation of customer responses.
• Performs assignments with instructions as to the general results expected.
• Communicates business-related issues or opportunities to next management level.
• Ensures personal and company compliance with all Federal, State, local, and company regulations, policies, and procedures for Health, Safety, and Environmental compliance.

Qualifications

• Minimum 3+ years of relevant experience with a Bachelor's degree; or equivalent education and experience; or an advanced degree with no previous professional experience.
• Where required, the role must hold an appropriate degree in the industry (e.g., Legal).
• Preferred Qualifications: Interventional Radiology/Cardiology or ICU experience preferred; Experience using vascular interventional devices is preferred; Equivalent combination of education and experience; Experience in the medical device industry preferred; Knowledge of Medical Device Complaint Handling and Reporting Regulations; Healthcare Certification and/or license in specific discipline preferred; Knowledge of product use in a clinical setting preferred; Excellent written and oral English communication skills; Proficient investigative and analytical skills; Computer literate of MS Word, MS PowerPoint, MS Excel preferred; Ability to interact with individual/groups at all levels, good presentation/training skills; Ability to identify priorities and function independently.