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Global Regulatory Labeling Manager

ZOLL Medical Corporation

ZOLL Medical Corporation

Legal
Chelmsford, MA, USA
Posted on Friday, December 8, 2023
Resuscitation, ZOLLMED.comAt 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 Resuscitation division of ZOLL Medical Corporation 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

The Global Regulatory Labeling Manager is responsible for defining strategies and provide strategic guidance to cross-functional departments to ensure product labels comply with global regulatory and product requirements.

Essential Functions
  • Provide technical leadership and support in the areas of labeling design and development, artwork control, and labeling policy and procedures. Maintain knowledge of product requirements and current rules and regulations governing global labeling activities, and track global labeling requirements to maintain compliance of product labels.
  • Lead or participate on cross-functional assignments and provides technical labeling design/development for new product and process development, and sustaining engineering activities.
  • Ability to lead a team to collaborate with key stakeholders to ensure and improve efficiencies throughout labeling documentation in accordance with regulatory and product requirements and best practices.
  • Improve labeling process and efficiency around label content development and maintenance. Support preparation of supporting documents for core labeling changes.
  • Assist with the support of the Regional Regulatory Leads in responding to queries related to labeling and collaborate with Regulatory Leads to identify and track country labeling differences.
  • Create, maintain, and update labeling procedures and SOPs and support relevant audits and inspections.
  • Provide training to internal stakeholders and new joiners on labeling process requirements.
  • Communicates clearly and effectively with cross-department personnel.
  • Participate in regulatory audits/inspections as required.

Required/Preferred Education and Experience
  • Bachelor's Degree required
  • 4+ years of label design and content management experience in the Medical Device Industry
  • Previous experience leading global regulatory labeling initiatives

Knowledge, Skills and Abilities
  • Extensive understanding of ISO 15223, ISO 20417, and other labeling standards and regulations
  • Familiarity with label content management software platforms
  • Strong 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
  • 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
  • Working knowledge of US and international medical device regulations
  • Strong understanding of medical terminology
  • Accomplishes department objectives by managing staff; planning and evaluating department activities.

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.

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.