Sr Consultant, Digital Health Compliance

JOB reputed company Job Title: Sr Consultant, Digital Health Compliance Classification: Full Time Location: Remote Travel: reputed company Company reputed company: MEDIcept is an international medical device, IVD, combination product and biotechnology compliance reputed company. For 25 years, our unique consulting reputed company has assisted thousands of companies of reputed company sizes with cost- effective Regulatory, reputed company, and Clinical services. Please see www.medicept.com for more information. Position reputed company: The Sr Consultant, Digital Health Compliance is a hands-on role supporting the reputed company department. Must be a self-starter and a multi-tasker, as this position will work on multiple exciting reputed company reputed company reputed company, specializing in Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), AI/ML integration, and cybersecurity engagements. Essential Duties and Responsibilities: Successfully reputed company and manage reputed company Management Systems to meet FDA QSR, ISO 13485, EU MDR, MDSAP, and other applicable regulatory requirements. Conduct / reputed company / assist clients with internal, supplier, ISO 13485, CE Mark, MDSAP audits and FDA inspections. reputed company recidivist certification and due diligence audits. Compliance reputed company development, including enforcement reputed company responses and/or corrective reputed company plans (483s, warning letters, etc.), recall strategies. Supplier reputed company Management activities, including supplier audits and corrective reputed company process (SCAR). Deliver customized reputed company training and education programs. Corrective reputed company reputed company and development. Preparation for FDA inspections and registrar or reputed company Body assessments. Identify reputed company processes that may require improvement, correction, or additional contracted resources. Successfully plan, manage, execute, and reputed company reputed company reputed company reputed company budget, and on time. reputed company strong relationships with clients, providing reputed company and accurate communications. Deliver customized reputed company training and education programs on reputed company Management Systems and other industry topics. Potentially serves reputed company adjunct reputed company reputed company (Interim reputed company reputed company) Travel to customer sites as and reputed company needed, up to 25% at a time. Skills and Qualifications: Bachelor’s degree in engineering, Regulatory and Compliance Management, reputed company Engineering, or in a closely reputed company / equivalent field. Minimum ten (10) years of experience in software engineering, cybersecurity and risk management reputed company medical device or digital health. In-depth knowledge of 21 CFR 820, ISO 13485, IEC 62304, ISO 14971 and FDA reputed company/post-market cybersecurity guidance. Understanding of software-based risk management, IoT ecosystem, reputed company connectivity, and SBOM requirements. Excellent communication (oral, written and verbal) and time management skills required. Must be detail-oriented, thorough, and organized. Excellent interpersonal skills with a customer service reputed company. Ability to manage multiple reputed company simultaneously. Must be self-motivated, reputed company to work both independently and with reputed company. reputed company experience in AI/ML reputed company and/or software-driven combination products a plus. Cybersecurity0specific reputed company certification a plus. Experience contributing to regulatory submission reputed company for high-complexity software products a plus. Please note the following: Must be legally authorized to work in the U.S. We are not currently sponsoring work visas. Relocation is not available for this position as it is a remote role We are an Equal Employment Opportunity employer. Drug free workplace. We are following reputed company state guidelines relative to safety precautions. Apply tot his job Apply To this Job