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 groups
- Working with department management provides global regulatory strategies and regulatory plans
- Working with department management, communicates with US FDA
- Coordinates/prepare and maintains FDA PMA and 510(k) Premarket Notifications in accordance with US FDA requirements
- Supports Reviews of product labeling changes
- Support CAPA and CAPA closure
- Participates in regulatory audits/inspections as required
- Perform other duties as assigned
Required/Preferred Education and Experience
- Degree in Regulatory Affairs or Regulatory Affairs Certification preferred
- Experience with medical device regulatory submissions (510(k) or PMA preferred
- Experience with medical device submissions preferred
- Commissioned Notary Public in the state of Massachusetts.
Knowledge, Skills and Abilities
- Project management skills
- Must be able to work under pressure to meet regulatory reporting time frames and company requirements
- Must be able to work with minimal supervision, recognize departmental needs and initiate/recommend actions for resolution
- Knowledge of U.S. and European/International regulations and standards
- Experience interacting with FDA and/or other regulatory agencies
- Must work well in team environments
- Must demonstrate leadership skills in team setting.
- Proven analytical abilities, Able to apply problem-solving skills for problems of moderate to diverse scope
- Solid understanding of manufacturing and change control, and an awareness of regulatory trends
- Understanding of engineering concepts and scientific terminology
- Superior interpersonal skills
- Excellent communication skills, both oral and written
- Proven ability to prioritize, conduct, and manage time to meet project deadlines
- Documented evidence of writing skills
- Basic understanding of computer applications-Strong knowledge of Microsoft Office package, Windows and e-mail systems. Working knowledge of desktop computer and other software programs
- Familiarity 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
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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.