ZOLL Medical
Regulatory Affairs Coordinator (Contract)
ZOLL Medical, Chelmsford, Massachusetts, us, 01824
Circulation, ZOLLMED.com
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.
This is a 6+ month contract position.
Job Summary
Responsible for preparing regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities.
Essential Functions
Supports in developing partnerships with quality assurance, manufacturing, program management, product development, and marketing to ensure product compliance and timely product clearances and/or approvals.Represent regulatory affairs on project/product teams, risk management, and all design review meetings.Working with department management provides regulatory guidance and guidance on applicable standards to cross-functional groupsWorking with department management provides global regulatory strategies and regulatory plansWorking with department management, communicates with US FDACoordinates/prepare and maintains FDA PMA and 510(k) Premarket Notifications in accordance with US FDA requirementsSupports Reviews of product labeling changesSupport CAPA and CAPA closureParticipates in regulatory audits/inspections as requiredPerform other duties as assignedRequired/Preferred Education and Experience
Degree in Regulatory Affairs or Regulatory Affairs Certification preferredExperience with medical device regulatory submissions (510(k) or PMA preferredExperience with medical device submissions preferredCommissioned Notary Public in the state of Massachusetts.Knowledge, Skills and Abilities
Project management skillsMust be able to work under pressure to meet regulatory reporting time frames and company requirementsMust be able to work with minimal supervision, recognize departmental needs and initiate/recommend actions for resolutionKnowledge of U.S. and European/International regulations and standardsExperience interacting with FDA and/or other regulatory agenciesMust work well in team environmentsMust demonstrate leadership skills in team setting.Proven analytical abilities, Able to apply problem-solving skills for problems of moderate to diverse scopeSolid understanding of manufacturing and change control, and an awareness of regulatory trendsUnderstanding of engineering concepts and scientific terminologySuperior interpersonal skillsExcellent communication skills, both oral and writtenProven ability to prioritize, conduct, and manage time to meet project deadlinesDocumented evidence of writing skillsBasic understanding of computer applications-Strong knowledge of Microsoft Office package, Windows and e-mail systems. Working knowledge of desktop computer and other software programsFamiliarity with medical terminology a plus
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
#LI-LV
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.
This is a 6+ month contract position.
Job Summary
Responsible for preparing regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities.
Essential Functions
Supports in developing partnerships with quality assurance, manufacturing, program management, product development, and marketing to ensure product compliance and timely product clearances and/or approvals.Represent regulatory affairs on project/product teams, risk management, and all design review meetings.Working with department management provides regulatory guidance and guidance on applicable standards to cross-functional groupsWorking with department management provides global regulatory strategies and regulatory plansWorking with department management, communicates with US FDACoordinates/prepare and maintains FDA PMA and 510(k) Premarket Notifications in accordance with US FDA requirementsSupports Reviews of product labeling changesSupport CAPA and CAPA closureParticipates in regulatory audits/inspections as requiredPerform other duties as assignedRequired/Preferred Education and Experience
Degree in Regulatory Affairs or Regulatory Affairs Certification preferredExperience with medical device regulatory submissions (510(k) or PMA preferredExperience with medical device submissions preferredCommissioned Notary Public in the state of Massachusetts.Knowledge, Skills and Abilities
Project management skillsMust be able to work under pressure to meet regulatory reporting time frames and company requirementsMust be able to work with minimal supervision, recognize departmental needs and initiate/recommend actions for resolutionKnowledge of U.S. and European/International regulations and standardsExperience interacting with FDA and/or other regulatory agenciesMust work well in team environmentsMust demonstrate leadership skills in team setting.Proven analytical abilities, Able to apply problem-solving skills for problems of moderate to diverse scopeSolid understanding of manufacturing and change control, and an awareness of regulatory trendsUnderstanding of engineering concepts and scientific terminologySuperior interpersonal skillsExcellent communication skills, both oral and writtenProven ability to prioritize, conduct, and manage time to meet project deadlinesDocumented evidence of writing skillsBasic understanding of computer applications-Strong knowledge of Microsoft Office package, Windows and e-mail systems. Working knowledge of desktop computer and other software programsFamiliarity with medical terminology a plus
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
#LI-LV
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.