Lead all aspects of the Regulatory, Regulatory Compliance, Quality Systems and Quality Initiatives for the Company in the areas of medical device manufacturing for USA, Canada and EU among other markets.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
Develop and implement a global regulatory compliance plan (North and South America, EU, MENA, Africa, Asia and Oceana) with the intention of opening these markets to our medical devices.
Develop Regulatory and Quality strategy for current and next generation products.
Ensure that the planned project activities are implemented (Project Management) and are compliant with the Del Medical Standard Operating Procedures (SOP’s), the FDA Quality System Regulation (QSR), MDSAP, Health Canada and ISO 13485:2016 requirements, with no major findings. Including Regulatory approvals and Post Market Reviews.
Serve as division’s management representative working with safety agencies test labs for certification such as FDA, ISO, UL, CSA, CE, etc.
Manage QA activities to ensure a reliable supply chain, consistent factory output and customer satisfaction.
Develop and sustain the Company QMS and ensure compliance to quality policies, objectives, and system metrics.
Lead management reviews and presentations for leadership, sales team, external conferences and recruiting events.
Train all applicable facility associates in CAPA root cause investigations.
Execute recall and field corrective action assessments.
Represent customer feedback and incorporate feedback into sustaining engineering.
Other duties that may be assigned
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, knowledge, skill, and/or ability required:
Bachelor’s Degree and/or documentation representing formal training and certifications in the field of Regulatory Compliance
Minimum of 5 years of prior work experience in a quality regulated environment, such as ISO 13485
Working knowledge of the following: interacting with Government officials, Quality Systems, warranty & product reliability, quality internal auditing, lead trainer regulatory affairs, statistical analysis, (RAPS) and (RAC) – Medical Devices, as well as, regulation standards and guidance documents.
Ability to work well under pressure, oversee multiple projects, meet deadlines, communicate effectively, both verbally and in writing, and have great interpersonal skills.
Internal Number: 241
About Del Medical, Inc.
DEL MEDICAL, Inc. is a leading source of innovative radiography products with over eighty years in the medical imaging business. It is primarily engaged in the design, manufacture and distribution of high performance digital and analog medical imaging systems which are sold and serviced through a global network of authorized and factory trained dealers. The company’s extensive selection of configurations and accessories is designed to support hospitals, imaging centers, and clinics by tailoring systems to accommodate each facility’s various sizes, requirements and budget.