NEED ONLY H1B WITH PASSPORT NUMBER
Hi,
Pleasure mailing you. Please go through the below requirement and let me know if you are comfortable for the position.
Please send me your updated resume along with the best hourly rate, work authorization status and availability.
An early response is really appreciated.
Job Title: Regulatory Engineer
Location: Wauwatosa, WI (Onsite)
Duration: 12+ Months
Job Description:
The team developing industry leading X-ray generation subsystems is looking for highly motivated regulatory engineers to join them in ensuring compliance and availability of these subsystems for CT scanners to all the global markets of interest.
Regulatory Engineer will be working on compliance activities for various medical devices global regulations.
Responsibilities
Collaborate with cross functional teams (engineering, manufacturing, regulatory, sourcing, etc.) to lead or support compliance activities to medical device regulations.
Review regulatory compliance change notifications and drive associated actions to be compliant by the effective date Lead compliance efforts to various global regulations (E.g. REACH, ROHS, etc.) in alignment with the quality management system Lead or support product regulatory documentation updates (e.g. NRTL reports, tech file, etc.) Support regulatory audits and inspections to ensure post-market surveillance compliance.
Qualifications we seek in you!
Minimum Qualifications
- Knowledge of medical regulations including FDA, EU MDR, NMPA/CFDA, and other applicable international regulations Knowledge of regulatory standards such as IEC 60601, ISO13485, 14971 and other applicable standards and substandard.
- Proficiency in interpreting, applying complex regulations, and preparing associated documentation.
- Excellent interpersonal communication and collaboration skills Bachelor’s degree in engineering, Science or related area Minimum of 2 years of experience working with medical devices regulations and quality management system.
- proficiency with written English and with neutral English accent
Preferred Qualifications/ Skills
- Strong technical knowledge
- Effective probing skills and analyzing / understanding skills Strong attention to detail.
Thanks,
Ch Anvesh Kumar
US IT Recruiter
LinkedIn: https://www.linkedin.com/in/anvesh-kumar-chitithoti-16780b24a/
Email: Anveshc@tekskillsinc.com | www.tekskills.in
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