Regulatory Specialist
Location :
Valley Cottage NY US 10989
Job Type :
Temp/Contract to Direct
Reference Code :
21080-BZ1
Compensation : open - 45-55/h
Start Date :
06/20/2022
Hours :
Full Time
Required Years of Experience :
3
Required Education :
BS Engineering or Science
Travel :
No
Relocation :
No
Job Industry :
Medical Devices
Job Description :
- Contract to direct position for a Regulatory Specialist for medical device manufacturing.
- Translate quality and regulatory requirements into quality assurance plans and instructions.
- Prepare and implement quality standards, operating procedures, work instructions and reporting systems.
- Conduct quality and regulatory training programs for personnel.
- Report in-house and field quality data and quality problems, recommend corrective action, and verify effectiveness of solutions.
- Conduct internal quality and vendor audits on a scheduled basis.
- Perform other duties as assigned.
Required Qualifications :
- BS Engineering or Science
- Internal Company orientation training.
- Training: ISO-13485 or similar quality system standard and quality auditing.
- External advanced QSR/GMP/ISO training.
- Related SOP training.
- Minimum 3 years experience with quality and regulatory affairs.
-
Intermediate Level Microsoft Office: Excel and Word.
-
Experience with internal auditing of Quality systems.
Contact: Bill Zukowsky
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