Regulatory Affairs Specialist

Regulatory Affairs Specialist

03 Jul 2022
Minnesota, Fridley, 55421 Fridley USA

Regulatory Affairs Specialist

Role: Regulatory Engineer
Location: Fridley, MN 55446
Experience: 1-6 yrs.

  • 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.

Vimerse is a fast growing IT Company having a team of well trained professionals and with a huge spectrum of services to offer. It s having Innovation and Reliability as its driving force. We are proud to say that with our fleeting yet diverse experiences we are able to become a partner of choice with an astonishing accomplishment and customer satisfaction for our clients.
Our main motive is to provide professional support system to our clients aligned to their core business activity with an aim to provide cost effectiveness and optimum utilization of available resource while keeping pace with dynamic market conditions.
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status

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