Post Market Surveillance Manager

Summary

Responsible for managing the Post Market Surveillance Process, including collecting, analyzing, and reporting on post market surveillance data for proactive identification of any performance trends or potential adverse safety risks or previously unidentified risks. Collaborates with cross-functional team members to ensure compliance with applicable regulations, standards, and the companies quality management system and policies. Maintains knowledge of applicable global regulations and industry standards to ensure high standards of quality, safety, and effectiveness of Biocares’ products.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Prepare PMS/PMPF/PSUR plans.
• Monitor timelines and coordinates collection of post market surveillance data.
• Analyze and interpret clinical and PMS data.
• Prepare PMS/PMPF/PSUR reports.
• Provide feedback from PMS analysis through feedback loop into design.
• Participate and provide input to Risk Management Process
• Assist with preparation and reporting of adverse reporting events globally.
• Support responding to requests for additional information from competent authorities, registries and notified body.
• Build working relationships with cross functional teams including R&D, Supply Chain, Manufacturing Operations, Sales, Quality Assurance, and Marketing to ensure process solutions are compliant, efficient, and adaptable to the business.
• Develops, reviews, and maintains SOPs as needed to ensure regulatory compliance.
• Other duties as assigned by Management.

Competencies

• BS/BA Degree with a minimum of six (6) years working in regulated medical device or pharmaceutical industry or MS Degree with four (4) years of relevant experience.
• Knowledge of domestic and international quality systems and other standards such as FDA QSR, IVDR, Canadian MDR, MDSAP, SFDA, ISO 13485, ISO 14971 and other applicable standards and regulations
• Experience performing and reporting on Post-Market Surveillance and Vigilance activities.
• Strong oral and written communication skills.     
• Able to set and drive timelines with cross-functional team to meet PMS Plan requirements.
• Able to support change initiatives, develop strong effective relationships with key resources and decision makers.
• Attention to detail and good organizational skills.              
• Demonstrates strong analytical, critical thinking, problem solving and investigative skills. 
• High level of reading comprehension.     
• Strong computer and internet research literacy. 
• Microsoft Office (Word, Excel, PowerPoint, Outlook) knowledge.

Expected Hours of Work

• 8 a.m. to 5 p.m. Monday - Friday and may require extended weekday or weekend hours depending on business needs.

Compensation Range

• $100,000 - $140,000 annual