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

MnRnL2diWlRqbS93VGVCcmxmU05jam8wM0E9PQ==
  • 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.
  • Minimum two (2) years of experience in software-based medical devices (e.g., SaMD or SiMD).
  • Experience in preparing (writing) domestic and international product submissions, required.

Pay Range: $86,000 - 120,000/yr

Job Tags

Similar Jobs

Innova Solutions

System Engineer Job at Innova Solutions

 ...Solutions has a client that is immediately hiring for a System Engineer Position type: Fulltime/Contract...  ...business requirements. Participate on IT Validation and Qualification testing activities covering Computer Systems, Computerized Equipment and IT... 

BIGFORK ACES INC

Summer Camp Counselor Job at BIGFORK ACES INC

Now Hiring: Summer Camp Staff at Bigfork ACES (Full & Part-Time)&##128205; Bigfork, MT | &##128467; June 10 August 8, 2025 | MondayFriday, Two Daily Shifts Bigfork ACES is seeking motivated, responsible, and compassionate individuals to join our team as Camp...

Golden Goose

Retail Salesperson Job at Golden Goose

 ...Golden Goose is looking for a passionate and customer-focused Part-Time Style Maker ! Ensuring high levels of customer satisfaction...  ...Guarantee a proper Customer Relationship Management, according with Company standard Embody and transmit with passion the company... 

Akkodis

Customer Service Representative Job at Akkodis

 ...background in Insurance/Health Insurance and working experience with claims and benefits, and...  ...: ~ Provide customer service via telephone or email to clients, providers, and plan...  ...optimize system performance and must meet at home technical requirements. ~ Proficiency... 

The Borgen Project

Public Relations/Marketing Internship Job at The Borgen Project

 ...of numerous bills that have benefitted close to 500 million people in developing countries. PR/Marketing Internship: This is a part-time 12-hours per week, 12 week, unpaid remote internship. If your availability is limited, you can work ahead and complete the program...