Post Market Surveillance Reporting Specialist I

Location: Chelmsford, MA


This role is part of ZOLL's Post Market Surveillance and Regulatory reporting program. Our Regulatory program is designed to meet the FDA's Quality System Regulation (QSR/Good Manufacturing Practices (GMP). This person will be instrumental in meeting Post Market Surveillance obligations surrounding submissions involving ZOLL devices domestically. There will be interdepartmental interactions surrounding Post Market Surveillance activity involving Quality Assurance, Compliance, Technical Support, Service, and Regulatory Affairs. There will be opportunities to showcase talents to improve, develop, and foster growth continuously.

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 of ZOLL develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. 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

A stakeholder in ZOLL's Post Market Surveillance process in accordance with the FDA's Quality System Regulation (QSR)/ Good Manufacturing Practices (GMP) and globally harmonized standard ISO 13485. Reviews and assesses complaint information received from Technical Support. Based on information received, determines if events meet appropriate regulatory requirements for adverse event reporting. Generate appropriate regulatory reports based on assessment, communicate with other Sub-Office departments globally and respond to regulatory authority requests. This involves written documentation, computer input and interactions with internal and external customers. This position performs evaluations, preparations for audits, review and submission of regulatory documents and some oversight of the regulatory affairs program. We pride ourselves on creating opportunities for growth.

Essential Functions

  • Maintain ZOLL's Post Market Surveillance in compliance within applicable regulations worldwide.
  • Support process improvement and continuous improvement initiatives.
  • Comply with U.S. Food and Drug Administration (FDA) regulations and other international regulatory requirements, company policies, operating procedures, processes, and task assignments.
  • Stay appraised with regulatory landscape updates, changes, and state of the art. Support initiatives to implement and assess gaps in the Quality Management System as it relates to Post Market Surveillance.
  • Maintain Regulatory Affairs databases, input data and control access as needed.
  • Maintain regular status reports of regulatory activities.
  • Review and assess product complaints for adequate information to determine if event meets Regulatory reporting requirements.
  • Communicate and support other ZOLL facilities and business partners globally as required.
  • Support Competent Authority inquiries, Adverse Event & Serious Injury reporting, and Risk Management activities world-wide.
  • Assist in project management in collaboration with core team members.
  • Track and communicate project status to all stakeholders by preparing status reports and participating in update meetings.
  • Generate sound rationales for non-reportable events based on regulatory knowledge and/or clinical experience.
  • Maintains positive and cooperative communications and collaboration with all levels of employees and customers.
  • Support auditing activities related to Post Market Surveillance.

Required/Preferred Education and Experience

  • Bachelor's Degree preferred
  • 6 years + in related field preferred
  • Certification in Regulatory Affairs program Preferred

Knowledge, Skills and Abilities

  • Has knowledge of commonly used concepts, practices, and quality tools, in a medical device environment (preferred).
  • Competent with MS Office, including Excel, Access, PowerPoint, Visio, and Word. Also operating with Oracle and Agile experience preferred.
  • Knowledge of FDA QSR, 803, and MDD is required. 2-5 years’ experience in an FDA and ISO regulated to Post Market Surveillance environment preferred
  • Ability to provide leadership, communicate and work effectively within a multi¬ disciplined organization
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Capable of mastering Post Market Surveillance software systems for submission.
  • Must maintain company quality and quantity standards
  • Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
  • Excellent organizational skills with ability to work within defined deadlines
  • Ability to work in collaborative and independent work situations and environments with minimal supervision.
  • Ability to leverage and/or engage others to accomplish projects
  • Action-orientated: Ability to take initiative to correct problems or make changes for improvement without waiting for direction.
  • Proven ability to work successfully with other departments

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' 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 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.