The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
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Medical Device, Quality/Risk Management, Regulatory Compliance
4 Year Degree
Under the supervision of site Compliance Manager, the Senior Compliance Engineer ensures the continuous education, implementation and improvement of site Compliance with FDA regulations, ISO standards and any additional regulations and standards applicable to the site such as 21 CFR Parts 4, 211 and 820, ISO13485, MDD/MDR, CMDR, TGA, JPAL and ANVISA requirements.
The Senior Compliance Engineer plans, conducts and directs compliance projects requiring advanced knowledge of a specialized field. The Senior Compliance Engineer applies comprehensive and diverse knowledge of quality systems within broad assignment areas. The Senior Compliance Engineer may coordinate and direct activities of technical support staff and be responsible for technical development of assigned staff. In addition to those activities pertaining to the Quality Engineer level of the position, the Senior Compliance Engineer also interacts with other franchise facilities to exchange support, and resources aimed to attain common compliance objectives. The Senior Compliance Engineer makes decisions and proposes solutions to issues which could preclude a timely or effective implementation of compliance programs and initiatives. The individual also interacts with the Quality Department’s projects of varied scope.
Internal Audit Program
External audit/inspection readiness activities
Compliance guidance/support for projects (site, multi-site, MD Sector or JJRC level)
Metrics collection and reporting
Regulatory compliance education and training
External Standards and Regulations
Site Management Review
Bachelor’s degree in Engineering or bachelor’s degree in scientific discipline
Minimum of 4 years of experience in highly regulated industry is required
Experience in Quality, Manufacturing or Engineering roles preferred.
Working knowledge of Medical Device or Pharma regulations is preferred
Experience leading or managing an internal audit program is preferred.
Good written and oral communication skills is required (report writing, presentation and training skills)
Accomplish objectives in a timely manner with minimum supervision.
Good interpersonal skills; customer service oriented.
Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) is required.
Current Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA) and/or Lead Auditor certification is preferred. The ability to become certified within 1 year if required.
Training in Process Excellence/Six Sigma tools and methodologies and Certification preferred.
Experience with Microsoft Project is preferred.
Experience in leading and managing projects and milestones preferred.
Experience with Minitab is preferred.
Internal Number: 2200191217
About Ethicon-Johnson and Johnson
Ethicon Inc. is recruiting for a Senior Compliance Engineer, located in San Angelo, TX.
Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.