Regulatory Engineer

We have a Permanent  for Regulatory Engineer for our client Fridley MN. Please let me know if you or any of your friends would be interested in this position.
 
Position Title:
Regulatory Engineer- Fridley MN
Location          : Fridley MN
Duration          : Fulltime - Permanent
 
Job Description :
 
 
Experience: 1-6 yrs.
 

• Industry: Regulatory, Medical devices, Companies: Healthcare, Stryker, Client, Johnson & Johnson, Client(Medical Device), Phillips (Medical Device),

• Regulatory knowledge (European Medical device directive and Medical device Regulation)
• Familiarity with standard related to Quality Management Systems (ISO 13485, 21CFR Part 820)
• Regulatory experience in Medical Device Registration Support- APAC, LATAM, EMEA, Canada, China, Russia, Japan. Medical device more relevant.
• EUMDR- EUMDD STED writing experience, EUMDR remediation experience.
• Project Management experience
• Experience in Regulatory assessment of Engineering/ Design change execution
• Very good written and oral communication in English.
• Ease for reading/creating/modifying documents.

 

• Able to work with minimal supervision. Self-motivated team player.

 
If you are interested in this opportunity, please email your resume at

and include posting     22-01157 in your application. also, you can call us at and to discuss this position details.
About Generis Tek: generis tek is a boutique it/professional staffing based in Chicagoland. we offer both contingent labor & permanent placement services to several fortune 500 clients nationwide.
Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients’ specific needs and working very closely with our consultants to create a right fit for both sides. we aspire to be our client’s most trusted business partner.