Keystone Industries Headquarters - Gibbstown, NJ

Dental Regulatory Affairs Manager

Website Keystone Industries

Dental Regulatory Affairs Manager

Position Overview

Provides professional regulatory support through independent management of assignments.  This includes but is not limited to maintenance and submission of regulatory filings, sharing and demonstrating current and accurate knowledge of products and regulatory requirements affecting products, interacting with others inside and outside the Company, and working with and assisting other Regulatory Affairs staff.  Supervises day-to-day activities and operations of Regulatory Affairs staff.

Direct Reports:  1

Essential Job Functions

  • Regulatory Filings – acts as liaison between Regulatory Affairs and internal/external customers and agencies
    • Submissions of new products for clearance in USA, EU, CAN, and other countries as requested
    • Annual drug establishment registration and national drug code listings
    • Annual medical device registration and listing updates
    • Other license renewals as needed
    • Foreign product registrations (foreign/international market registrations)
  • Regulatory Requests – provide product/technical data to customers
    • Generate, request, and obtain regulatory certificates (Certificates of Foreign Government/Certificates of Pharmaceutical Product)
    • Apostille of regulatory statements and regulatory certificates
    • Completion of customer surveys and/or questionnaires
    • Provide overall regulatory support and guidance
  • Project Management/Design Control
    • Advise project teams on premarket regulatory requirements
    • Advise on export and labeling requirements
    • Provide guidance for all other regulatory compliance hurdles
  • Supervision of Staff
    • Lead and mentor Regulatory associates regarding regulatory requirements, internal/agency systems and product team interactions
    • Provide guidance and assign projects/tasks

Additional Job Functions:

  • Identify and research relevant guidance documents, international standards, and provide interpretations
  • Regularly monitor the regulatory landscape and communicate regulatory changes to appropriate departments
  • Good Manufacturing Practice & Good Documentation Practice Requirements Training* –performed 2x/year; including but not limited to:
    • Prepare, instruct, evaluate, record/track results of training
      *training is performed at Gibbstown and Cherry Hill facilities
  • Internal Auditing
  • Provide guidance/assistance to quality assurance and document control staff as needed

Qualifications

  • Minimum 5 – 7 years’ directly related experience in a regulatory position, including medical devices
  • Demonstrated knowledge of 510(k) submissions, EU Technical File Submissions, and Health Canada Medical Device License applications
  • Demonstrated knowledge of ISO 13485 & ISO 9001
  • Demonstrated knowledge of cGMP
  • Familiarity with international market labeling and registrations
  • Strong problem solving and multi-tasking skills
  • Strong computer skills including Microsoft Office Suite
  • Excellent writing skills – position requires technical writing/documentation

Desired Skills

  • Experience with the FDA UDI (Unique Device Identifier) initiative
  • Microsoft Dynamics (AX) a plus
  • Audit experience
  • Training and supervisory experience
  • RAC, or equivalent certificate from a university
  • Ability to navigate highly ambiguous situations
  • Well organized, articulate, a self-starter, responsive and a team player

 

Education/Certifications:

  • Bachelor’s Degree in engineering or chemistry/science-related field

 

To apply for this job email your resume in Word or PDF format to careers@keystoneind.com

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