Senior Post-Market Surveillance Specialist

Bisco • Schaumburg, IL

1d • $81,000 - $95,000 • Hybrid

About The Position

This position will have the option to work a hybrid schedule, with two days from home after three months of employment, with the remainder working in our office out of Schaumburg, IL. BISCO is seeking a Senior Post-Market Surveillance Specialist who will own and evolve our Post-Market Surveillance (PMS) processes across the organization. This role goes beyond document preparation. It requires working with cross-functional teams and driving clarity across varying inputs and perspectives. The ideal candidate is comfortable making decisions in evolving situations, can influence without direct authority, and brings clear recommendations rather than open-ended analysis. This role requires both independent ownership and the ability to engage leadership as a thought partner, bringing forward direction while incorporating feedback. This position will plan, execute, and continuously improve Post-Market Surveillance processes and support Clinical Evaluation Reports throughout the product life cycle.

Requirements

• Bachelor’s degree required. Advanced degree preferred. Degree in science, medicine, dentistry, or similar discipline highly preferred.
• Minimum of 5 years professional experience including medical/technical writing experience.
• Experience authoring, EU MDR compliant, medical device Post-Market Surveillance reports preferred.
• Detailed knowledge of relevant MDCG guidance preferred.
• Familiarity with relevant international regulatory requirements and guidance documents for medical devices, including MEDDEV 2.7/1 revision 4
• Familiarity applying research methodology and information management.
• Experience in the medical device industry, within a Quality Management System preferred
• Proficient in MS Office applications (Word and Excel) and email systems.
• Strong organizational and follow-up skills, as well as attention to detail.
• Strong English writing and communication skills

Responsibilities

• Own, plan, author, and maintain Post-Market Surveillance documentation, including Post-Market Surveillance (PMSP/PMSR), Periodic Safety Update (PSUR), Post-Market Clinical Follow-Up (PMCFP/PMCF)
• Drive clarity and consistency in PMS inputs across cross-functional teams
• Identify opportunities to improve inputs and partner with leadership to enhance data quality and reporting
• Provide clear recommendations and decision direction on PMS-related topics rather than open-ended analysis
• Review and provide guidance on Clinical Evaluation Reports (CERs)
• Author the Summary of Safety and Clinical Performance (SSCPs)
• Assist in the review of General Safety and Performance Requirements and Essential Principles in design and development
• Interpret clinical, scientific, and risk data to support regulatory submissions and product decisions
• Interprets results in preparation for product applications by evaluating clinical, scientific, risk data, and literature while staying abreast of current clinical practice
• Monitor post-market surveillance and clinical regulatory requirements and trends as part of the Regulatory Intelligence process
• Participate in the development of regulatory responses for Notified Body submission questions
• Contribute to the risk management process, ensuring integration of clinical and PMS data
• Support development and implementation of global clinical regulatory strategies for new and legacy devices
• Bring forward clear recommendations rather than open-ended analysis
• Lead discussions on complex topics and help drive toward decisions
• Engage leadership as a thought partner while maintaining ownership of outcomes
• Take initiative to improve how information is gathered and used across teams
• Influence cross-functional stakeholders to drive alignment and consistency
• Use sound judgment to determine when to act independently and when to align
• Simplify complex situations into clear, actionable direction

Benefits

• Medical, dental, and vision insurance
• HRA and FSA
• Short and long-term disability
• Life insurance
• Pet insurance
• PTO
• 401(k) profit-sharing with match
• Potential year-end bonuses

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees