Dental Regulatory Affairs Team Lead

Pennsauken, NJ

Posted: 05/30/2018 Industry: Laboratory - Industrial Chemicals Job Number: 228.18LR Pay Rate: 60,000 - 80,000

Dental Regulatory Affairs Team Lead

The Dental Regulatory Affairs Team Lead will provide 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.

  • 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 assigned projects/tasks
  • 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 twice a year; including but not limited to:
    • Prepare, instruct, evaluate, record/track results of training
  • Internal Auditing
  • Provide guidance / assistance to quality assurance and document control staff as needed

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Larry Riederer at 815.756.1221 / larry@cps4jobs.com.

JO:  228.18LR
#LI-LR1

Requirements:

  • BS Chem or similar with minimum of 5-7 years’ relevant 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 computer skills including Microsoft Office Suite
  • Excellent writing skills – position requires technical writing/documentation
  • 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, self-starter, responsive and a team player
  • Ability to prioritize and track multiple concurrent projects
  • Ability to communicate effectively, especially through written media
  • Strong leadership skills
  • Excellent interpersonal skills
  • Must be flexible and collaborative
  • Strong problem solving and multi-tasking skills

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Larry Riederer at 815.756.1221 / larry@cps4jobs.com.

JO:  228.18LR

#LI-LR1

Larry Riederer
Market Specialist

I have over 20 years of experience with Chemical Personnel Search (CPS) . All we do is recruit and place people in the chemical industry nationwide. CPS has been recruiting chemists, engineers, sales people and supply chain since 1973. I work with 40 other recruiters. 


I have a wide range of positions and levels.
The following are some of the areas: Polymers, Resins, Coatings, Adhesives, Inks, Composites, Plastics, Lubricants, Personal Care, Skin/Hair Care, Cleaners and Specialty Chemicals.

These can be: Organic/Polymer Synthesis, New Product Development, Analytical/Characterization, Quality Control, Process Development, Materials Science and others. These are from BS to Ph.D. and from Entry Level to Vice-President. 

Specialties: We specialize in placing Chemists, Scientists and Managers in the industrial chemical industry

 

For more information please reach out!

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