Project Manager, Post-Market Surveillance

Job Summary

The Project Manager, Post-Market Surveillance (PMS) will support the intra-departmental PMS functions, including Quality, Regulatory, Engineering, and Marketing. This position will support ongoing PMS activities with a focus on sustaining and improving product quality. The Project Manager will interact with the company's quality and compliance management as well as all complimentary departments in the achievement of organizational goals. The individual must have exceptional organizational capabilities and be able to multi-task to provide support on quality initiatives and projects. This person must also be detail-oriented and able to provide hands-on, individual contribution as needed to meet Quality department goals and objectives.

Duties & Responsibilities

• Manage the overall Masimo PMS activities to ensure compliance to EU MDR and other evolving regulatory requirements.
• Develop a knowledge of Masimo products and their performance.
• Identify and communicate emerging trends to drive product improvements.
• Ensure PMS activities are established and maintained for Masimo products.
• Identify core team members for specific product lines and work cross-functionally with other teams to compile and generate PMS data according to the PMS Plan.
• Develop PMS plans, generate PMS reports and review with identified/responsible teams.
• Monitor the ongoing compliance of Masimo's PMS System and escalate any issues for resolution.
• Review changes to Masimo's procedures and documentation and confirm adequacy and completeness of PMS documentation.
• Represent Quality Compliance department in PMS related meetings and provide quality/compliance input to ensure ongoing compliance.
• Generate/update PMS system procedures as required (e.g., SQP, SOP, protocols and reports).
• Develop and maintain up-to-date knowledge on regulatory compliance, specifically FDA and EU requirements.
• Performs other duties or special projects as assigned.
  
  
  
  • Must have experience and working knowledge of quality system and practices, including Post-Market Surveillance (PMS)
  
  

Minimum & Preferred Qualifications and Experience

Minimum Qualifications

• Must be able to provide guidance to functional teams on PMS requirements
• Experience in Quality Systems per ISO 13485
• Ability to work in a Project Team Environment
• Computer Proficiency with MS Office (Word/Excel/Access/Outlook)
• Excellent verbal and written communication skills
• Excellent prioritizing, organizational, and interpersonal skills
• Excellent documentation skills including detail-oriented, record maintenance/ tracking and understanding of document traceability
• A detail-oriented individual, with a "can do" attitude, and the ability to work in a team environment, as well as individually (with minimal supervision)
• Ability to work in a fast-paced environment, with multiple tasks/projects

Preferred Qualifications

• Experience in patient monitor systems, hospital-based products, software or electronic device products
• Experience with EU MDR and EU harmonized standards
• Experience interacting with regulatory bodies, such as the Notified Body
• Experience with FDA/GMP requirements for medical device

Education

BA/BS Degree or equivalent combination of education and experience is required. Will consider graduate degree in Quality or Regulatory to offset a lack of professional experience.

Compensation: The anticipated range for this position is $90,000 to $130,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver's license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.