Sr. Regulatory Affairs Specialist Job at PRISMATIK DENTALCRAFT, INC., Irvine, CA

WlpEUGx1cXB6SXdJN3EwRWtjYzdUVG5QTFE9PQ==
  • PRISMATIK DENTALCRAFT, INC.
  • Irvine, CA

Job Description

Prismatik Dentalcraft is a division of Glidewell Dental.

Essential Functions :

  • Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies.
  • Maintains company registrations and device listings in the US, Canada, and the EU.
  • Analyzes and reports department metrics.
  • Supports and maintains technical files, MDD certifications, and declarations of conformity in support of EU product registrations/CE mark.
  • Informs coordinator of product recalls.
  • Performs and supports internal, external, and third-party audits.
  • Maintains knowledge on current regulations and guidelines.
  • Evaluates compliance with applicable regulations, project policies, and procedures
  • Reviews and writes standard operating procedures (SOPs) and other RA/QA policies as necessary.
  • Collaborates with technical staff to foster understanding of SOPs and guidance documentation.
  • Composes audit plans and reports.
  • Conducts audits and inspections of GMP and non-regulated documentation.
  • Tracks internal and external corrective and preventive actions.
  • Performs other related duties and projects as business needs require at direction of management.

Education and Experience:

  • Bachelor’s degree in related field preferred
  • Minimum five (5) years of experience in Regulatory Affairs.
  • Experience in preparing (writing) domestic and international product submissions, required.

Pay Range: $83,898.06 - 120,000.00/yr

Job Tags

Similar Jobs

CRH

Accounting Supervisor Job at CRH

Job ID: 510550 CRH's Americas Materials, a division of CRH, is the leading vertically integrated supplier of aggregates, asphalt, ready mixed concrete and paving and construction services in North America. Our operations span North America with over 28,000 employees...

CSBimpact Marketing & Media Management

Remote work | Senior Digital Media Specialist Job at CSBimpact Marketing & Media Management

 ...Location: San Diego, CA | Indianapolis, IN Area | Freelance / Remote / Hybrid Position: Senior Digital Media Specialist Job Description: CSBimpact is a small but mighty marketing agency based in San Diego with a digital outpost in Indianapolis. Our team is... 

Lake City Plating

Chief Financial Officer (Part-Time) Job at Lake City Plating

 ...sharp, and thoughtful financial leader to join our team as our part-time CFO , working approximately 25 hours per week, with a blend...  ...orders. Summary The CFO leads the companys finance, accounting, and procurement functions, overseeing the infrastructure,... 

Southern Ag Carriers, Inc

Logistics Freight Broker Job at Southern Ag Carriers, Inc

 .... The company was founded over 25 years ago in Albany, GA. Role Description This is a full-time on-site role for a Freight Broker at Southern Ag Carriers, Inc. The Freight Broker will be responsible for freight brokerage, customer service, dispatching, and account... 

Courier Express

Warehouse Operations Manager Job at Courier Express

 ...Transportation Manager $50k a year depending on experience Purpose of the Position: Oversees daily Operation processes and activities. Primary Job Duties: Supervises multiple operating units (warehouse / distribution center) with part time and full-time...