Merakey Jobs

POSITION OVERVIEW Have a passion for regulatory affairs? Interested in medical software? Look no further! We are looking for a savvy and passionate Senior Regulatory Affairs Specialist to join our team here at Canon Medical! As the Senior Regulatory Affairs Strategist, you will champion U.S. pre-market activities including new product planning and remedial actions on released products. You will also support the development and implementation of long-range regulatory strategies for medical software product clearance in the U.S. RESPONSIBILITIES Implement and execute regulatory QMS documentation strategies to ensure compliance with U.S. requirements. Organizing pre-sub meetings with FDA. Generate and submit HIT 510k submissions. Provide regulatory input and support for product development and change control processes. Prepare, review, and submit regulatory documentation to the FDA for new products and product changes to ensure timely approval for market release in accordance with all applicable regulations, standards, and guidance. Coordinate responses for requests for additional information. Collaborate with internal teams such as Engineering and Product Management to establish and maintain robust quality management systems and processes. Review, advise and provide guidance to technical, marketing and sales personnel on Marketing and Sales promotion materials for compliance with regulatory guidelines. Support and organize discussions with FDA on product submissions and pre-submission meetings. Support legal/regulatory actions as required by the legal department or directed by the Senior Director, Regulatory Affairs. Recommend process improvements related to regulatory affairs, including document control, change control, and training. Performing analysis of competitor's/predicate regulatory filings. Support the analysis of regulatory paths during the early concept phase based on alternate market requirements & value propositions. Provide support and guidance on clinical validation requirements. Advise on regulatory requirements for new market entries and product expansions. Participate in regulatory agency interactions, such as meetings, audits, and inspections, and effectively communicate the company's position. Provide input to the regulatory group in European Union (EU) to assure that there is consistency in meeting regulatory requirements. Stay informed about emerging trends, regulations, best practices in the software and healthcare industries and share regulatory updates, insights, and recommendations with internal stakeholders. REQUIRED EDUCATION AND SKILLS Bachelor's Degree in Regulatory Affairs or Engineering Sciences required, Master's degree preferred 4+ years' experience in regulatory affairs, preferably in the software, medical device, or healthcare industry Experience with generating and submitting 510k submissions Experience with FDA QSR, ISO 13485, IEC 62304 for software lifecycle management, ISO 14971 and EN 62366 Knowledge of current U.S. laws pertaining to software as a medical device FDA product (Class ll) submission Experience with FDA E Star electronic submission process preferred Experience with software automation, Artificial Intelligence, CAD(e), CAD(x), and CAD(t) type submissions preferred Excellent verbal and written communication skills as well as presentation skills. COMPANY OVERVIEW At Canon Medical Informatics (formerly Vital Images, Inc.), what we do matters. This is at the heart of every product we develop, every service we provide, and especially each member of our team. As part of Canon Medical Systems Corporation, we lead the industry with the latest health imaging informatics solutions. We improve the quality of patient care by developing innovative products that enable the exchange, analysis and storage of clinical information across health care enterprises and communities. Our products handle millions of medical images and health records a day across the world. Canon Medical Informatics e periences the best of both worlds with a dynamic and collaborative environment, casual culture, and agility of a mid-sized company, while having the support and resources of Canon Medical Systems Corporate, our parent company. Our offices are based in Minnetonka, Minnesota; Waterloo, Ontario; Copenhagen, Denmark; The Netherlands; and Beijing, China. We value our team's innovation, enthusiasm, and dedication to help improve the lives of patients. Do you want to be part of a passionate team that believes what we do matters? Then a career with Canon Medical Informatics might be right for you! COMPANY VALUES Unity, Courage, Tenacity, Teamwork, and Excellence WHAT WE OFFER YOU Canon Medical Informatics offers a dynamic workplace, competitive compensation package, and room for learning and growth in our organization. This is an environment in which things move quickly and you'll have the opportunity to wear many hats. We have a casual dress code, offer flexible work hours and actively foster work-life balance, because anything else simply isn't sustainable. Our Minnetonka, MN office is located about 12 miles southwest of downtown Minneapolis. Our office is near several walking paths and restaurants that are a quick drive away. In our office of 175, we have on onsite deli, workout facility and weekly massages. Our team loves what we do and has fun doing it together. We look forward to receiving an application from you. Canon Medical Informatics is an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, color, religion, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Vital Images is an Equal Opportunity Employer, M/F/Vets/Disability.