Job Description

Job Description

Job Description

Salary: $67,000 - $84,000

At PRC-Saltillo, our mission to provide voices to children, teens, and adults who are unable to communicate effectively with their natural voices. Each year, we provide voices to thousands of individuals through our specialized communication devices, software, and apps. We serve those with autism, cerebral palsy, Down syndrome, ALS, aphasia, and a variety of other medical conditions. Our products not only provide the ability to speak, but open opportunities for education, employment and fuller participation in life.

All applicants need to go to our website to apply  saltillo.com/careers.

Education and Experience:

• Bachelor’s Degree in a business, engineering, quality or compliance related field is required.
• At least five years of manufacturing compliance, quality control, or corporate auditing experience is required.
• At least one year of experience with European Union Medical Device Regulation required.
• Experience working at a medical device company a plus.
• Knowledge of ISO 13485 preferred.

Duties and Responsibilities

• Develops and maintains an understanding of compliance obligations relevant to the existing and proposed company product offerings and keeps up to date on all applicable laws, regulations, and compliance guidance in relevant jurisdictions for current and proposed product offerings including the regulations of the European Union Medical Device Regulation (EUMDR) and the US Food and Drug Administration (FDA).
• Prepare the required documentation for the labs performing compliance testing and certification. Works closely with the lab and engineering during testing to ensure the devices meet the compliance requirements.
• Validates compliance testing recommendations of laboratories used to conduct product testing.
• Collaborates with product design, development, and engineering personnel to ensure an understanding of product requirements, applicable regulatory requirements, compliance options, and associated risks.
• Assists product design, development, and engineering personnel in prioritizing and implementing measures to comply with applicable regulations for medical and consumer products in various markets including for product design and development, market performance and accessibility.
• Maintains a Library of Standards to provide the latest standards.
• Maintains accounts for the company's FDA Global Unique Device Identification Database, the European and Swiss Medical Device databases, and other relevant country product databases for product support.
• Responsible for related technical documentation including risk analyses, declaration of conformities, technical files, usability study documentation, and related forms and work instructions to ensure compliance.
• Serves as backup on document control systems for implementation, support, training, and improvement activities.
• Performs other duties as assigned.

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