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Product Development/Regulatory Scientist
Ref No.: 18-07221
Location: Irwindale, California

Shift/Hours: M-F
Job Description: Participate in New Product Development and Life Cycle Management projects within a Microbiology laboratory to develop, support, and conduct catheter and accessory product design verification testing, process and sterilization validations to ensure compliance with company Quality System policies, procedures, standards (FDA, ISO 13485, CMDCAS, PMDA) and other worldwide regulatory agencies that pertain to medical devices. This position is located in Irwindale, CA.

KEY ACTIVITIES

Primarily support multi-faceted areas including but not exclusive to the Microbiology Laboratory, Environmental Monitoring, Sterilization and other NPD production floor activities associated with IQ/OQ/PQ/TMV/Software validations and product supply chain support, which may include quality investigations
Responsible for scientific documentation and timely evaluation of changes to existing products, material, and process changes for potential biocompatibility hazards within a Risk Management Framework in compliance with global medical device regulations
Responsible for generation of test plans, coordination of sample tests, and final reports suitable for regulatory submission as well as for the accuracy and integrity of documentation generated
Exercises technical judgment in selecting and justifying appropriate biocompatibility test methods, techniques and criteria
Perform literature searches in support of selection and justifications
Coordinate chemical characterization testing between internal clients and internal service providers


REQUIRED EXPERIENCE

Environmental Monitoring experience is required for this role (medical device industry preferred)
Sterilization Validation experience is required for this role (Ethylene Oxide modality preferable)
Bachelor or Master Degree in any sub-field(s) of Biology/Biochemistry/Chemistry/Toxicology with 5+ yrs. industry experience (medical device industry preferred)
Direct industry experience with ISO 10993, 21-CFR, PART 58 regulations
Experience with critical evaluation of both In Vivo and/or In Vitro toxicological studies
Experience in materials biocompatibility and toxicological assessments for medical devices preferred
Design and interpretation of appropriate chemical and toxicological studies to support product development and regulatory submissions.