Senior Post-Market Surveillance Specialist
BISCO Dental Products, Schaumburg, IL, United States
Position:
Senior Post-Market Surveillance Specialist
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.
Salary and Benefits Salary range: $81K-$95K, commensurate with experience
Medical, dental, and vision insurance
Health Reimbursement Arrangement (HRA) and Flexible Spending Account (FSA)
Short- and long-term disability
Life insurance
Pet insurance
PTO
401(k) profit-sharing with match
Potential year-end bonuses
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
Interpret 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
Role Expectations
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
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.
Hours: 8:00 a.m. to 4:30 p.m., Monday-Friday
EOE
No agencies please.
#J-18808-Ljbffr
Senior Post-Market Surveillance Specialist
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.
Salary and Benefits Salary range: $81K-$95K, commensurate with experience
Medical, dental, and vision insurance
Health Reimbursement Arrangement (HRA) and Flexible Spending Account (FSA)
Short- and long-term disability
Life insurance
Pet insurance
PTO
401(k) profit-sharing with match
Potential year-end bonuses
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
Interpret 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
Role Expectations
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
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.
Hours: 8:00 a.m. to 4:30 p.m., Monday-Friday
EOE
No agencies please.
#J-18808-Ljbffr