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Title

Regulatory Affairs QA Manager 

EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.  
Description

About the role:

 

We are seeking Regulatory Affairs Manager who will be reporting to the VP of Regulatory Affairs. This is hands-on working manager position will lead the day-to-day operational activities of the department and ensure that the project/s, department milestones and goals are met.

 

This position is based at Sciton’s headquarters in Palo Alto, CA

 

 

Responsible for:

  • Coordinate inspection of the organization and contract facilities (if applicable), provide support during audits and/or investigation(s) and develop procedures to ensure regulatory compliance.
  • Oversee the regulation process for products requiring governmental approval and handling all domestic and international government interactions.
  • Obtain regulatory approvals and certifications for the company as and when necessary; 510(k)’s, ISO 9001, ISO 13485, QSR, CE and foreign government regulatory approvals.
  • Facilitate external inspections, audits and investigations; FDA (Fed and State), KFDA, ANVISA, etc., as well as TUV, EHS, fire department, etc., to ensure regulatory compliance.
  • Perform internal audits annually and whenever necessary to ensure continued regulatory compliance.
  • Generate CHRH product reports and maintain CDRH annual reports and VA quarterly reports.
  • Process clinical complaints and maintain customer service and clinical complaints files for USFDA, EU-MDR, and regulatory reporting.
  • Generate regulatory procedures as necessary to efficiently operate the business.
  • Provide leadership to assure that products meet quantity, cost, quality and regulatory objectives.
  • Support R & D efforts and direct product transfer to manufacturing.
  • Improve manufacture of existing products by streamlining and automating processes where necessary.
  • Generate and maintain all DHF’s, including facilitating risk management, design reviews and formal product transfer.
  • Has full authority for personnel actions.
 
Position Requirements

Experience / Education / Skill:

  • Direct experience with 510(k)’s, De Novo, IDE, CE, ANVISA, COFIPRIS, TGA, HC, MFDS, NMPA, PMDA, TFDA, etc. is highly desirable.
  • Requires 10 years of experience in the related area as an individual contributor.
  • 1 to 3 years supervisory experience is preferred.
  • Requires a bachelor's degree in area of specialty, technical degree is preferred.
  • Able to work with cross-functionally with other departments to understand the requirements that require support.
 
Full-Time/Part-Time Full-Time  
Position Regulatory Affairs Manager  
Location Palo Alto (HQ)  
About the Organization SCITON, a privately held and employee-owned company headquartered in Palo Alto, California, is a leading manufacturer of medical and aesthetic lasers and light source technologies. Founded by the laser industry's preeminent engineers and physicists, our mission is to provide best-in-class solutions to improve human conditions.



Our culture and company strength stems from our diverse collection of talented and motivated employees. One word that best describes Sciton is ‘Family' because we treat each team member like family. We give our employees the support, recognition, and room to grow their careers within Sciton.



We empower our people to develop their creative geniuses. In fact, we incentivize creativity and innovations to all our people. We look for lifelong learners, problem solvers, and individuals who excel in a challenging, team-oriented environment. We hire individuals who want to retire with us. How do you feel about that?

 

This position is currently accepting applications.

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