What are the responsibilities and job description for the Manager Clinical Post Market Compliance position at ZOLL Medical Corporation?
Acute Care Technology
At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.
The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.
At ZOLL, you won't just have a job. You'll have a career\u2014and a purpose.
Join our team. It's a great time to be a part of ZOLL!
Job Summary
Responsible for managing Clinical Post Market Compliance Activities for ZOLL Medical Corporation. Lead a team ensuring products meet regulatory standards. Works closely with Regulatory Affairs related to Post Market Surveillance, product maintenance, and registration.
Essential Functions
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
ZOLL Medical Corporation appreciates and values diversity. We are an Equal Opportunity Employer M/F/D/V.
ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.
The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.
At ZOLL, you won't just have a job. You'll have a career\u2014and a purpose.
Join our team. It's a great time to be a part of ZOLL!
Job Summary
Responsible for managing Clinical Post Market Compliance Activities for ZOLL Medical Corporation. Lead a team ensuring products meet regulatory standards. Works closely with Regulatory Affairs related to Post Market Surveillance, product maintenance, and registration.
Essential Functions
- Management of direct reports
- Maintain compliance with global medical device regulations (EU MDR, FDA, ISO, etc.).
- Manage clinical and post-market documents (CERs, PMS/PMCF reports, SSCPs, PSURs).
- Monitor regulatory changes and update procedures accordingly.
- Support clinical affairs and risk management by aligning with regulations.
- Assess clinical risks and coordinate recalls with PMSR teams.
- Assist with regulatory submissions and agency communications.
- Develop strategies for clinical and post-market compliance and collaboration.
- Provide clinical inputs to post-market surveillance and adverse event reporting.
- Analyze clinical data and safety signals to improve product safety.
- Collaborate with internal teams (Regulatory, Quality, R&D, Medical Affairs).
- Stay updated on regulatory trends and industry best practices.
- Optimize processes for efficiency in evaluations and documentation.
- Work on regulatory data management systems.
- Bachelor's Degree or accredited management certification (Regulatory certification preferred).
- 7-9 years in a medical device environment preferred
- 4-6 years of management experience preferred
- Clinical or bedside experience preferred
- Capable of managing people at different levels.
- Excellent verbal & written communication skills.
- Proficient with FDA QSR, ISO13485, MDD, EU MDR, and ISO14971 for Medical Devices.
- Ability to lead discussions and meetings effectively.
- Ability to meet objectives, prioritize and execute strategies in a timely manner.
- Exceptional organizational skills.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Standing - Occasionally
- Walking - Occasionally
- Sitting - Constantly
- Talking - Occasionally
- Hearing - Occasionally
- Repetitive Motions - Frequently
ZOLL Medical Corporation appreciates and values diversity. We are an Equal Opportunity Employer M/F/D/V.
ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
