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.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Medical Device, Quality/Risk Management, Regulatory Compliance, Submission & Registration
4 Year Degree
Develop, submit, maintain, and monitor standard operating procedures, policies, practices, and reports to assure compliance with all FDA and international medical device regulatory requirements and applicable standards.
Prepares and evaluates regulatory documents and company specific SOP's, product manuals, Instructions for Use (IFUs), process flows and work instructions to maintain FDA QSR & ISO 13485 compliance.
Prepares and assists in review and submission of regulatory submissions, product registrations and technical dossiers to FDA and EU Notified Bodies
Audit and monitor internal processes and contract facilities for compliance with regulatory requirements, including FDA, CE, and ISO in application to medical devices.
Support the QMS by providing compliance expectations and actively interface with other functional areas on systems development and implementation.
Coordinate with Chief Science Officer the regulatory clinical efforts, including establishing and maintaining clinical protocols, informed consent, IRB submissions, trial monitoring, data preservation, and record keeping.
Maintain close liaison with regulatory authorities (domestic and foreign) and clinical, scientific, and manufacturing collaborators on matters that impact the regulatory responsibilities of the company.
Prepare and submit IDE’s, 510(k)s, Pre-Market Approval (PMA) Applications, PMA supplements and other regulatory submissions, requests, correspondence, and reports to the FDA and foreign equivalents, as required.
Participate in the product development process to assure products are designed in compliance with FDA regulations and applicable international quality systems standards.
Propose, develop and implement approved quality and regulatory policies and strategies.
Manage the content of the design files in relation to changes to devices, in the production process, and feedback gained from the marketplace.
Marketing control through post-market surveillance, medical device reporting and control of marketing materials; review promotional literature, product labeling, and website content for compliance to FDA and foreign equivalents regulatory expectations.
Design, develop, and deliver regulatory training to employees.
Maintain currency in regulatory science and communicate pertinent and relevant information which impacts or could impact corporate strategies.
Participate in face-to-face and teleconference discussions with staff of the US FDA and foreign regulatory equivalents.
Take a lead position in any onsite inspection by FDA or other regulatory authority.
Experience: Quality Assurance & Regulatory Affairs: 3 years (required) in the areas of quality assurance, regulatory audits and compliance, project registration, compliance or quality systems of medical devices
Education: Bachelor’s degree is required; a scientific or heath care related field is preferred
Reports to: President
Supervises: Quality Assurance Manager
Location: Mineral Wells, Texas; open to remote work for highly qualified individual
Internal Number: RA
About Electromedical Products International, Inc.
Electromedical Products International (EPI), www.alph-stim.com, designs, produces, and sells FDA cleared devices that treat anxiety, insomnia, depression, and pain. EPI is well established (30+ years-old), growing and profitable, and is located in the western Fort Worth, TX area.