Offer summary

Qualifications:

Bachelor's Degree or accredited management certification, preferably in Regulatory affairs., 7-9 years of experience in a medical device environment, with 4-6 years in a management role., Knowledge of FDA QSR, ISO13485, MDD, EU MDR, and ISO14971 for Medical Devices is essential., Excellent verbal and written communication skills, along with strong organizational abilities..

Key responsabilities:

Manage Clinical Post Market Compliance Activities and lead a team to ensure regulatory standards are met.

Maintain compliance with global medical device regulations and manage clinical and post-market documents.

Monitor regulatory changes, support clinical affairs, and assess clinical risks.

Collaborate with internal teams and optimize processes for efficiency in evaluations and documentation.

Job description

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—and 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.

Required/Preferred Education and Experience

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

Knowledge, Skills and Abilities

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.

Physical Demands

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 is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients's lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

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

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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.

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