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Manager, Regulatory Affairs

Location: Chelmsford, MA

Resuscitation

Job Summary:

The Regulatory Affairs Manager is responsible for overseeing the 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 oversee he preparation, monitor and communicate status of regulatory submissions to appropriate departments.

Essential Functions:

  • Manage, direct and support the Regulatory Affairs team. Hire, train, develop, teach, coach, mentor, motivate, discipline, and reward staff members.
  • Meet regularly with direct reports to review performance, identify any issues and set expectations of goals.
  • Prioritize and plan work activities; adapt for changing conditions.
  • Responsible for product submissions license renewals, periodic updates and registrations with domestic and international regulatory agencies.
  • Responsible for assembling required documentation for all classes of medical devices; communicate /and give guidance to other departments regarding format and timeline expectation.
  • Coordinate responses to regulatory agencies and notified bodies as part of the submission and approval processes.
  • Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies.
  • Review and approve Engineering Change Orders/Change Requests in accordance with regulatory requirements.
  • Lead regulatory compliance activities.
  • Responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations.
  • Review, interpret, and report to the head of Regulatory Affairs on product specific regulatory issues.
  • Acquire and maintain current knowledge of applicable regulatory requirements.
  • Interface with other functional departments to influence efficient execution of projects; provide regulatory support on project teams.
  • Manage team of 1-4 regulatory professionals and provide oversight and guidance on regulatory strategies, submissions, and projects.
  • Develop and mentor Regulatory Specialists, Senior Specialist and Associates.
  • Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance team’s/company’s knowledge of working in a regulated environment.
  • Manage team's employee development and succession planning activities; set performance objectives, provide coaching/guidance, and provide performance evaluation.
  • Other responsibilities as assigned.

Skill Requirements:

  • 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 travel is required ~ 10%
  • Management, leadership and mentoring skills and experience

Required/ Preferred Education and Experience:

  • Bachelor's degree
  • 8+ 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. 

ADA:  The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990

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