Plasma Medical Device Compliance Specialist
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Mobile, AL 36607
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the evaluation, review and approval of validation and quality assurance/control documentation. Mainly focus on Medical Devices regulations including 510(k) processes.
Primary responsibilities for role:
+ Coordinate and assist in validation activities associated with medical devices used within Biomat USA
+ Assist in ensuring validation approaches are current to regulatory expectations and standards within the industry
+ Write and/or review Risk Analysis documents
+ Write test cases to validate critical control points, user requirements, and functional designs
+ Execute test cases, as needed
+ Analyze validation data to ensure acceptance criteria are met
+ Write and/or review Traceability Matrix
+ Prepare validation reports
+ Evaluate adequacy of corrective actions
+ Coordinate and assist in regulatory activities associated with medical devices used within Biomat USA
+ Contribute to 510(k) Premarket Notifications assessments for new and existing medical devices
+ Write and/or review regulatory documentation
+ Support FDA new and ongoing submission processes and associated departments
+ Assist in the development of cGMP operating procedures that relate to process, computer systems, equipment validation, medical devices and 510(k) regulatory processes
+ Review all change requests for changes that impact medical devices
+ Be a regular impact assessor of all medical device-related changes within Biomat USA
+ Collaborate with other departments within the organization and act as liaison for quality and regulatory items associated with medical devices
+ Ensure milestones and timelines are met on assigned projects
EDUCATION & EXPERIENCE REQUIREMENTS
+ Bachelor’s degree.
+ Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
+ Typically requires 2 years of quality and validation experience in a cGMP and/or IT environment.
+ Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures. Excellent quantitative and analytical skills. Excellent oral and written communication skills. Strong critical thinking and problem solving skills. Ability to identify errors and provide corrective action. Ability to work with others in a team environment. Knowledge of Microsoft Office applications and computer applications used in the Donor Centers.
+ Occupational Demands Form # 34: Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32
- and high levels of noise in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. May stand; bends and twists neck and waist for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Repetitive foot movements. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures.
50% travel is required.
Learn more about Grifols
Req ID: 88072
Type: Regular Full-Time
Job Category: Others