We Are Looking for Temporary RA Specialists in Vista, CA!
Target Start Date: January 2nd, 2018
Contract: 6 months
Job Description:
Responsible for researching and executing regulatory tasks of moderate scope, complexity and risk. Performs regulatory due diligence of moderate complexity such as Class II products and requires the use of discretion and independent judgment when making decisions. Tasks may include proficiency at assignments such as establishment registration & listing, export certificate submissions, international product registrations, new product development support as well as the ownership of medium sized Regulatory Affairs projects.
Minimum Qualifications:
•3+ Yrs Exp
•BA/BS or Equiv Wrk Exp
Preferred Qualifications:
•Regulatory Affairs Certification (RAC)
•5+ Yrs Exp
Additional Job Descriptions:
The individual must have knowledge and understanding of ISO 13485:2003/2012 and ISO 13485:2016 requirements. Must understand the differences between the two revisions. Must be able to conduct a gap analysis to identify the gaps. Must be able to update/revise/create procedures based on ISO 13485:2016 requirements. Must be able to train departments to the new changes. Must be lead auditor certified by an accredited company. Must have an excellent communication skills and be able to work with different departments throughout the company.
AND/OR
The individual must have knowledge and understanding of US FDA, Canada, Australia, Brazil & Japan regulations. Must be able to implement these regulatory requirements into company’s Quality Management System through MDSAP. Must understand the grading system of MDSAP and be able to carry out the MDSAP audit for each site. Must be lead auditor certified by an accredited company. Must have an excellent communication skills and be able to work with different departments throughout the company.
Please email a copy of your resume to Jessica.Blume@DJOGlobal.com if you are interested in this position. Thank you.
http://www.djoglobal.com/
Contract: 6 months
Job Description:
Responsible for researching and executing regulatory tasks of moderate scope, complexity and risk. Performs regulatory due diligence of moderate complexity such as Class II products and requires the use of discretion and independent judgment when making decisions. Tasks may include proficiency at assignments such as establishment registration & listing, export certificate submissions, international product registrations, new product development support as well as the ownership of medium sized Regulatory Affairs projects.
Minimum Qualifications:
•3+ Yrs Exp
•BA/BS or Equiv Wrk Exp
Preferred Qualifications:
•Regulatory Affairs Certification (RAC)
•5+ Yrs Exp
Additional Job Descriptions:
The individual must have knowledge and understanding of ISO 13485:2003/2012 and ISO 13485:2016 requirements. Must understand the differences between the two revisions. Must be able to conduct a gap analysis to identify the gaps. Must be able to update/revise/create procedures based on ISO 13485:2016 requirements. Must be able to train departments to the new changes. Must be lead auditor certified by an accredited company. Must have an excellent communication skills and be able to work with different departments throughout the company.
AND/OR
The individual must have knowledge and understanding of US FDA, Canada, Australia, Brazil & Japan regulations. Must be able to implement these regulatory requirements into company’s Quality Management System through MDSAP. Must understand the grading system of MDSAP and be able to carry out the MDSAP audit for each site. Must be lead auditor certified by an accredited company. Must have an excellent communication skills and be able to work with different departments throughout the company.
Please email a copy of your resume to Jessica.Blume@DJOGlobal.com if you are interested in this position. Thank you.
http://www.djoglobal.com/