A national provider of plastic injection molding services

Regulatory/Quality Systems Specialist

Posted on: 11-19-2013

Qualifications: 

·       Bachelor’s Degree in Engineering, Science, or health-related field

·       3-5 years related work experience

·       Working knowledge of FDA and other regulatory authorities

·       FDA Regulatory submission experience (510ks, PMAs, IDEs)

·       Quality Systems development, implementation, and training experience

·       International submission experience (CE Mark, MDL, MDEL)

·       Experience with ISO 13485, FDA, MDD (EU Medical Device Directive), and CMDD (Canadian Directive) compliance requirements and training

·       Experience with Risk Management per ISO 14971

·       Experience with FDA remediation, Warning Letters, 483 Observations, and Recalls a plus

·       Candidate must be a self-starter, self-motivated, and results oriented

·       Excellent interpersonal and written communication skills

·       Must be able to work independently and have ability to work with cross-functional teams

·       Extensive project management skills with the ability to work under tight timelines and able to multi-task 

Responsibilities: 

·       Assist with premarket FDA and international regulatory submissions

·       Assist with development and/or revision of Quality System procedures and processes

·       Assist with internal and supplier audit development, implementation, and execution

·       Serve as a company representative during external audits by Regulatory and Third Party Auditors

·       Design Control documentation assistance

·       Validation and Testing Protocol Development

·       Perform gap assessments against new and revised Quality Modules, Quality Directives, and ISO requirements 

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