RA SPECIALIST-UDI - Waukesha, WI - Georgia IT Inc.
Waukesha, WI
About the Job
JOB TITLE/TYPE : RA SPECIALIST-UDI
Location : Waukesha, WI
Duration : 2 Years+
Rate : market
Note from the hiring Manager:-
"Typically we are looking at candidates who have > 2 -3 years of experience in regulatory affairs and pre market submissions in medical devices.
Function: Quality Family: Regulatory Affairs
Description:
The Regulatory Affairs Specialist works with a team of Regulatory Affairs professionals to ensure completion of Product Controllership and UDI deliverables in the area of product remediation and new product development.
Key responsibilities/essential functions include:
Create Registration program records for US registered products in IRIS (International Regulatory Information Systems)
Create US country records for each registration program in IRIS
Complete UDI attributes for each US country record (includes identification of data values via existing 510(k) records) in IRIS
Collaborates with product engineering and marketing to establish Product Models based on regulatory filings
Completes association of Product Models to US country records in IRIS
Creates and completes the Device Authorization Matrix for the product with inputs from commercial, supply chain and engineering.
Quality Specific Goals:
1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required.
4. Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility
Required Qualifications:
1. Bachelor's Degree (or international equivalent) in a related field such as: Regulatory Science, Biomedical Engineering, Biology, Chemistry, English (with a technical writing emphasis), Legal Studies, Law, Nursing, Physician Assistance, Pharmaceutical Science, Pharmacy OR minimum of 4 years progressive regulatory affairs experience in medical device or pharmaceutical industry or medical product regulation agencies, including knowledge and experience applying drug or device laws and regulations
2. Strong analytical skills
3. Ability to work in a team environment with minimal supervision on projects and activities
4. Ability to prioritize, plan & evaluate deliverables
5. Knowledge & experience conducting scientific, regulatory, legal, or business research.
6. Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner
7. Experience using spreadsheet and presentation software
8. Must be willing to travel up to 5% of the time
Preferred Qualifications:
1. Advanced degree in scientific, technology or legal disciplines.
2. Regulatory Affairs Certification (RAPS).
3. Experience in a medical device or pharmaceutical industry.
4. Knowledge of Quality Management Systems (QMS).
5. Experience working across cultures/countries/sites.
6. Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL.
7. Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
8. Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies.
Location : Waukesha, WI
Duration : 2 Years+
Rate : market
Note from the hiring Manager:-
"Typically we are looking at candidates who have > 2 -3 years of experience in regulatory affairs and pre market submissions in medical devices.
Function: Quality Family: Regulatory Affairs
Description:
The Regulatory Affairs Specialist works with a team of Regulatory Affairs professionals to ensure completion of Product Controllership and UDI deliverables in the area of product remediation and new product development.
Key responsibilities/essential functions include:
Create Registration program records for US registered products in IRIS (International Regulatory Information Systems)
Create US country records for each registration program in IRIS
Complete UDI attributes for each US country record (includes identification of data values via existing 510(k) records) in IRIS
Collaborates with product engineering and marketing to establish Product Models based on regulatory filings
Completes association of Product Models to US country records in IRIS
Creates and completes the Device Authorization Matrix for the product with inputs from commercial, supply chain and engineering.
Quality Specific Goals:
1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required.
4. Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility
Required Qualifications:
1. Bachelor's Degree (or international equivalent) in a related field such as: Regulatory Science, Biomedical Engineering, Biology, Chemistry, English (with a technical writing emphasis), Legal Studies, Law, Nursing, Physician Assistance, Pharmaceutical Science, Pharmacy OR minimum of 4 years progressive regulatory affairs experience in medical device or pharmaceutical industry or medical product regulation agencies, including knowledge and experience applying drug or device laws and regulations
2. Strong analytical skills
3. Ability to work in a team environment with minimal supervision on projects and activities
4. Ability to prioritize, plan & evaluate deliverables
5. Knowledge & experience conducting scientific, regulatory, legal, or business research.
6. Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner
7. Experience using spreadsheet and presentation software
8. Must be willing to travel up to 5% of the time
Preferred Qualifications:
1. Advanced degree in scientific, technology or legal disciplines.
2. Regulatory Affairs Certification (RAPS).
3. Experience in a medical device or pharmaceutical industry.
4. Knowledge of Quality Management Systems (QMS).
5. Experience working across cultures/countries/sites.
6. Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL.
7. Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
8. Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies.
Source : Georgia IT Inc.
