Job Description :

DigitalTek Solutions is a staffing company providing technical & non-technical recruitment solutions with over 10 years pertaining to the statement of work-based managed services staffing, staff augmentation and IT consulting services to 1000 fortune companies within North America.

Our niche is top-notch talent acquisition for Information technology, Engineering and the Digital sector within banking, financial, insurance, capital markets, telecom, manufacturing, utility & energy and plenty of other domains in NAM and LATNAM regions.

Sponsorship: Our clients will sponsor visa applicants; one must be open to relocate or travel within USA on reimbursed expenses.

Terms: Long term contract and/or Full time/Permanent.

Role: Regulatory Engineer

Location: Fridley, MN, & Plymouth,MN (Remote to start)

Experience: 1-6 yrs.

Industry: Regulatory, Medical devices, Companies: Medtronic, Stryker, Zimmer, Johnson & Johnson, GE(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.

Client : Major Consulting


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