RAQA Executive, Regulatory Affairs - Watson Health

Company: IBM Computing
Location: Cambridge
Posted on: May 12, 2022

Job Description:

IBM RAQA Executive, Regulatory Affairs - Watson Health in Cambridge , Massachusetts Introduction At IBM, work is more than a job - it's a calling: To build. To design. To code. To consult. To think along with clients and sell. To make markets. To invent. To collaborate. Not just to do something better, but to attempt things you've never thought possible. Are you ready to lead in this new era of technology and solve some of the world's most challenging problems? If so, lets talk. Your Role and Responsibilities As RAQA Executive, Regulatory Affairs and member of the Watson Health RAQA Organization, you will support global Regulatory Affairs for all of Watson Health. You will use your knowledge of global medical device regulations and standards to support the development of products for Watson Health. You will interface with the business and marketing leaders, the solution teams, regulatory, legal and other stakeholders to maintain compliance for the products. This position is located in our Cambridge, MA location. Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding post-market submissions, pre-submission strategy/regulatory pathway development, testing requirements, clinical study requirements, or clarification and follow up of submissions under review. Participates or leads FDA, notified body, and other regulatory bodies audits Work with regulatory experts to ensure the practice/organization has and maintains appropriate compliance forms, information notices and materials reflecting regulatory requirements for the target markets for Watson Health and Watson Health Imaging. Evaluates proposed products for regulatory compliance requirements internationally Ensures the development of quality and regulatory procedures for incorporation into the QMS to support target markets Ensures compliance and supports regulatory applications, as well as internal regulatory file documentation to achieve market clearances in US, Canada, EU, Brazil, Japan and Australia as applicable. Collaborates with regional business partners to support international product registrations. Leads the development of regulatory department policy and procedure implementation. Reviews device labeling and promotional materials for compliance with global submissions and applicable regulations. Stays current on new regulations through regulatory intelligence monitoring. Performs all duties and responsibilities as required by the Quality Management System Policies and Procedures Build quality into all aspects of their work by maintaining compliance to all quality requirements Leads cross functional teams for assigned projects Coaches, mentors and trains junior staff members Basic Qualifications BA/BS in a scientific discipline including a minimum of 20 years in healthcare medical device or life sciences pharmaceutical experience. At least 12-15 years' experience with job title/experience related to Quality Engineer, Quality Systems or Regulatory Affairs Well versed in medical device regulations in accordance with USA, Canada, Brazil, Japan, EU, UK, Australia and Singapore requirements. Excellent interpersonal, communication, and negotiation skills Required Technical and Professional Expertise Bachelor's degree in a scientific or technical discipline required; advanced degree preferred Preferred professional certifications: RAPS- RAC. Proficient knowledge of global regulatory submission requirements for medical devices; software medical devices preferred. General understanding of product development process and design control Proficiency with Microsoft Word, Excel and PowerPoint required. Effective research and analytical skills Effective written and oral communication, technical writing and editing skills Ability to work independently with minimal supervision Preferred Technical and Professional Expertise

• N/A About Business UnitIBM's Cloud and Cognitive software business is committed to bringing the power of IBM's Cloud and Watson/AI technologies to life for our clients and ecosystem partners around the world. IBM provides you with the most comprehensive and consistent approach to development, security and operations across hybrid environments-with complete software solutions for business and IT operations, development, data science, security, and management. Our experts and software capabilities help organizations develop applications once and deploy them anywhere, integrate security across the breadth of their IT estate, and automate operations with management visibility. With IBM, you also have access to new skills and methods, governance and management approaches, and a deep ecosystem of industry experts and partners. This job requires you to be fully COVID-19 vaccinated prior to your start date, where legally permissible. Proof of vaccination status will be required. If you are unable to be vaccinated due to medical, pregnancy or religious reasons, we offer accommodations in accordance with applicable law. Your Life @ IBMAre you craving to learn more? Prepared to solve some of the world's most unique challenges? And ready to shape the future for millions of people? If so, then it's time to join us, express your individuality, unleash your curiosity and discover new possibilities. Every IBMer, and potential ones like yourself, has a voice, carves their own path, and uses their expertise to help co-create and add to our story. Together, we have the power to make meaningful change - to alter the fabric of our clients, of society and IBM itself, to create a truly positive impact and make the world work better for everyone. It's time to define your career. About IBMIBM's greatest invention is the IBMer. We believe that through the application of intelligence, reason and science, we can improve business, society and the human condition, bringing the power of an open hybrid cloud and AI strategy to life for our clients and partners around the world.Restlessly reinventing since 1911, we are not only one of the largest corporate organizations in the world, we're also one of the biggest technology and consulting employers, with many of the Fortune 50 companies relying on the IBM Cloud to run their business. At IBM, we pride ourselves on being an early adopter of artificial intelligence, quantum computing and blockchain. Now it's time for you to join us on our journey to being a responsible technology innovator and a force for good in the world. Location StatementIBM offers a wide range of resources for eligible IBMers to thrive both inside and outside of work. In addition to a competitive benefits program consisting of medical and life insurance, retirement plans, and time off, eligible employees may also have access to: *12 weeks of paid parental bonding leave. Family care options are also available to support eligible employees during COVID-19. *World-class training and educational resources on our personalized, AI-driven learning platform. IBM's learning culture supports your restless attitude to grow your skills and build the depth and scale of knowledge needed to achieve your career goals. *Well-being programs to support mental and physical health. *Financial programs that empower you to plan, save, and manage your money (including expert financial counseling, 401(k), IBM stock discount, etc.). *Select educational reimbursement opportunities. *Diverse and inclusive employee resource groups where you can network and connect with IBMers across the globe. *Giving and volunteer programs to benefit charitable organizations and local communities. *Discounts on retail products, services, and experiences. We consider qualified applicants with criminal histories, consistent with applicable law. IBM will not be providing visa sponsorship for this position now or in the future. Therefore, in order to be considered for this position, you must have the ability to work without a need for current or future visa sponsorship. Being You @ IBMIBM is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics. IBM is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

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