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

bm9yQTM1MjcvSW52eXNtaU9uNXl3a1k0
  • 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: $83,000 - 120,000/yr

Job Tags

Similar Jobs

JSG (Johnson Service Group, Inc.)

Customer Service Representative 1 Job at JSG (Johnson Service Group, Inc.)

 ...training, a supportive environment for learning and growth, top pay and benefits, and a culture that is built on the highest standards...  ...vision, life insurance options, short-term disability, 401(k), weekly pay, and more. Johnson Service Group (JSG) is an Equal... 

SyllogisTeks

Low Voltage Technician Job at SyllogisTeks

 ...Lead Low Voltage Implementation Specialist 70 % Travel Chicago, Atlanta, Dallas, Arizona, CA Must live close to an airport Preferred...  ...above listed items is BIG plus ~5+ years of Low Voltage Technician or Project Engineer experience. ~5 years of experience... 

Maimonides Medical Center

Social Worker - Caring for Caregivers (Per Diem) Job at Maimonides Medical Center

 ...largest healthcare system, serving over 250,000 patients each year through the systems 3 hospitals, 1800 physicians and healthcare...  ...judgment. Hourly Pay: $45.81 - $64.77 (based on experience). Monday-Friday. Social Worker, for immediate consideration, please apply... 

bet365

SEO and Content Manager Job at bet365

 ...27 languages. Our focus on In-Play betting has solidified our market-leading position, offering an unmatched experience across 96 sports...  ...for our customers worldwide. Job Description As a SEO Manager on the Performance Marketing team you will be responsible for... 

RMD Group

Sous Chef at Rustic Root Solana Beach Job at RMD Group

 ...cooksand dish team. Type:Salary, Full Time Pay Scale:$69K-75K Duties and...  ...limited to:~ Monitor the production of food preparation andservice ~ Monitor all...  ...properly Ability to work in a stressful, fast-pacedenvironment Must be able to work...