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Senior Regulatory Affairs Specialist

Location: Chelmsford, MA

Resuscitation

Job Summary:

The Senior Specialist, Regulatory Affairs 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.

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, EU Notified Bodies, EU Competent Authorities and other international regulatory authorities
  • Coordinates/prepare and maintains FDA PMA and 510(k) Premarket Notifications in accordance with US FDA requirements
  • Coordinates/prepare and maintains CE files in accordance with current Medical Device Directive requirements, manages Essential Requirement checklists and ensures timely updates for all applicable CE certifications
  • Coordinates and prepares responses to FDA/NB or other such regulatory agency letters.
  • Supports Reviews of product labeling changes
  • Reviews promotional literature and marketing materials
  • Support CAPA and CAPA closure
  • Keeps apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company
  • Participates in regulatory audits/inspections as required
  • Writes SOPs and train key personnel as needed
  • Perform other duties 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
  • 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%

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. 

 

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

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