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Manager, Regulatory Affairs

Manager, Regulatory Affairs

Job ID 
2018-1247
Job Locations 
US-MA-Chelmsford
Category 
Quality, Regulatory Affairs, and Service
Type 
Full-Time/Regular

More information about this job

Overview

ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success.

 

We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL!

 

Job Summary:

 

The Regulatory Affairs Manager is responsible for preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities. This position will also prepare, monitor and communicate status of regulatory submissions Reports to Associate Director, Regulatory Affairs.

 

 

Responsibilities

  • Lead regulatory affairs focused projects that produce new and/or improved strategies, processes, procedures and protocols to ensure internal and external compliance. Drive RA focused projects and act as project lead where required.
  • Develop and/or improve development processes, procedures and protocols that assist in meeting internal SOP’s, FDA and industry regulations. 
  • Determine global regulatory strategies for market introduction of new and modified devices/platforms.
  • Ensure proper communication of regulatory strategies to responsible functions, including Product Development, Sales, Marketing, Service, Manufacturing and Executive Management (as necessary). 
  • Prepare and maintain US and non-US product submissions (510(k), PMA and PMA Supplements, Technical Files, Canadian Licenses and International registrations). 
  • Participate in product development teams, as well as, review, analyze and comment on technical protocols and reports.
  • Provide guidance and training to teams as necessary on regulatory requirements. 
  • Plans, reviews, tracks, executes, approves all forms of quality systems requirements such as CAPAs, change orders, regulatory assessments 
  • Provide regulatory reports and inputs to management as necessary. 
  • Translate the regulatory requirements into the relevant implementation.
  • Interact with US and non-government officials on product approvals and during audits. 
  • Ensure proper facility registrations and device listings with appropriate regulatory agencies.
  • Performs other duties as needed and assigned. 

Qualifications

  • Project management skills 
  • Degree in RA or Regulatory Affairs Certification a plus 
  • 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
  • Ability to understand, evaluate, and provide guidance on scientific literature, reports, and rationales
  • Experience reviewing technical and design specifications
  • 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
  • Familiarity with medical terminology a plus
  • Some overnight travel required

Required/ Preferred Education and Experience:

  • Bachelor's degree
  • 6+ years of regulatory experience in the Medical Device Industry
  • Experience with medical device regulatory submissions (510(k) or PMA)
  • Previous experience working with Regulatory Authorities relative to premarket and compliance activities.
  • Experience with medical device submissions.

 

Other Duties:

 

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity. Essential and marginal job functions are subject to modification.

 

ZOLL Medical Corporation appreciates and values diversity.  We are an Equal Opportunity Employer M/F/D/V.