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.