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Senior Regulatory Affairs Specialist

Company Name: Zest Dental Solutions
Location: Carlsbad, CA
Job Type: Full Time
Contact Name: Debra Isaacs
Phone: 1-760-705-1123
Fax:
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary:

Job Description

The Senior Regulatory Affairs Specialist will support the Regulatory Affairs department with all aspects of the Regulatory function. 

  • Plan and preparation of global regulatory dossiers including documentation required for 510(k), Health Canada submissions, Medical Device Technical Files in accordance with MDD and MDR, and ROW submissions.
  • Assist the Regulatory Affairs Director and Manager with Regulatory activities to ensure compliance with the new European Medical Device Regulations (MDR).
  • Ensure compliance with US and international regulations and guidelines.
  • Provides routine regulatory support, which may include, but not limited to:
    • Support the compilation, development, submission, and maintenance of worldwide regulatory filings;
    • Track regulatory project status and informational documents;
    • Create timelines and tracking deliverables to timelines to ensure that all submissions are submitted on-time;
    • Interface with global Regulatory partners and internal cross functional teams; and,
    • Attend relevant functional area and project team meetings as required.

Other duties as assigned


Job Requirements 

  • Senior Regulatory Affairs professional with a minimum of 5-10 years experience authoring medical device Technical Files, in accordance with MDD, successfully approved by European Notified Body for CE marking. Must be able to work independently with minimum direction from supervisor. Must have experience in label review/approval for CE marking. Must be knowledgeable in MDR requirements. Experience in the dental field preferred.
  • Bachelor’s Degree in biology, chemistry, biochemistry, microbiology, or related discipline.
  • Experience with the use of spreadsheets, word-processing, and database application software (i.e. Excel, Adobe, Word).
  • Flexibility and agility to accommodate constant project changes and time constraints.
  • Ability to work in collaborative and independent work situations with minimal supervision.
  • Demonstrated interest and capability in learning subject matter and processes.
  • Demonstrated ability to solve problems with limited or no supervision.
  • Demonstrated effective interpersonal, teamwork, and communication skills required.
  • Ability to use Regulatory information systems.
     

To apply, please email resume to:  This email address is being protected from spambots. You need JavaScript enabled to view it.