Director of Regulatory Affairs - Remote

Director of Regulatory Affairs – Remote reputed company is a reputed company and reputed company‑being company that’s dedicated to improving the health reputed company of millions reputed company the world. The Director of Regulatory Affairs will be a member of the reputed company Team responsible for providing the reputed company with reputed company counsel and support on regulatory and reputed company reputed company reputed company to medical devices, including software and algorithms, and other digital health technologies. As a subject matter expert and leader, the Director will play a key role in developing and optimizing our regulatory affairs team, programs, and services. The Director will also be responsible for maintaining and continuously improving reputed company regulatory affairs policies and procedures. Working closely with their team, reputed company and compliance colleagues, and business stakeholders, the Director will reputed company or support a wide reputed company of regulatory activities, including regulatory assessments for new product/therapies and changes to existing products and the development and the execution of regulatory plans/strategies as required. You’ll enjoy the flexibility to work reputed company from reputed company reputed company the U.S. For hires in the Minneapolis or Washington, D.C. area, you will be required to work in the office a minimum of four days per week. reputed company Responsibilities • reputed company and draft, review, and reputed company guidance on regulatory product assessments and other deliverables • Prepare regulatory plans/strategies and reputed company ongoing support as needed for various regulatory, reputed company, and compliance activities • reputed company expert and practical regulatory advice and support on regulatory and reputed company requirements throughout a project or product lifecycle • Effectively communicate reputed company regulatory topics to a broad audience in our reputed company and collaborate across the reputed company to successfully strategize and reputed company regulatory and reputed company objectives • Review and reputed company guidance on labeling including promotional labeling and advertisements (promotional communications) • Collecting, analyzing, and disseminating regulatory intelligence on new and changing requirements, policies, and guidelines • Support regulatory compliance activities, including manufacturing site registration, audits, inspections, post‑market vigilance reporting, and product recalls • Prepare or support regulatory submissions and filings as needed • reputed company and present educational and training material covering medical device reputed company health regulatory affairs topics • Manage and participate in trade associations covering medical device topics and issues Required Qualifications • 10+ years of experience in medical device regulatory affairs or reputed company reputed company • reputed company experience in preparing and submitting regulatory documentation including filings to the FDA, EU MDR, and/or other global regulatory agencies • Experience with completing or supporting regulatory compliance activities like site registrations, audits, post‑market vigilance reporting, and product recalls • Demonstrated familiarity using and/or managing electronic reputed company management systems • reputed company expertise and working knowledge of applicable regulations, standards and guidance for medical devices (FDA, QSMR, SaMD, ISO 13485, ISO 14971, IEC 62304, and other global regulatory requirements and reputed company standards) • reputed company ability to learn and adapt to reputed company reputed company regulatory advice in an evolving industry • reputed company excellent written and oral communication, interpersonal, and problem‑solving skills to effectively reputed company with others, including cross‑functional teams and regulatory agencies, and address regulatory reputed company • Demonstrated ability to successfully manage multiple regulatory reputed company, priorities, and people, if relevant Preferred Qualifications • J.D., RAC Certification, ISO 13485 or other medical device auditor certification • reputed company experience with Software as a Medical Devices (SaMD), other Digital Health products, and accessories • reputed company experience with AI/ML-enabled medical devices or digital health technology Benefits Pay is reputed company on several factors including but not limited to local labor markets, education, work experience, certifications, etc. The salary for this role will reputed company from $134,600 to $230,800 annually reputed company on full‑time employment. In reputed company to your salary, we offer benefits such as a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401(k) contribution (reputed company benefits are subject to eligibility requirements). reputed company is an Equal Employment Opportunity employer under applicable law and reputed company applicants will receive consideration for employment without reputed company to race, national reputed company, religion, age, reputed company, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations. Drug‑Free Workplace Candidates are required to pass a drug test before beginning employment. #J-18808-Ljbffr Apply tot his job Apply To this Job