Senior Regulatory Affairs Specialist - Neuromodulation (Pain) Careers that Change Lives The Senior Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining approval for products and therapies to markets worldwide. In this role, you will ensure compliance with relevant FDA, MDD, ISO and other global regulations, for neurovascular products. You will support local RA to interact with regulatory authorities to assure timely new product introductions and continued product access. You will work on PMA activity and participate on internal development teams, providing US and/or International regulatory strategy and execution. You will lead and execute complex regulatory projects. The Senior Regulatory Affairs Specialist International will provide regulatory review of labeling and advertising, design changes, and specification changes. Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. To learn more about Inclusion & Diversity at Medtronic Click Here A Day in the Life • Define the regulatory strategy and manage regulatory submission activities for new product development activities and product maintenance for existing approved products. • Team with business unit, Regulatory Affairs Specialists (RAS), and international regulatory staffs to provide regulatory support for new products/therapies and changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. • Prepare FDA submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release. • Provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status. Interact directly with FDA and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager. • Provide business and product information to international regulatory staffs to enable development of strategies and requirements, and communicate that information to business teams. • Provide feedback and on-going support to product development teams for regulatory issues and questions. • Ensure personal understanding of all quality policy/system items that are personally applicable. • Follow all work/quality procedures to ensure quality system compliance and high quality work. • Comply with applicable FDA and international regulatory laws/standards and the Medtronic Code of Conduct • May travel : 10-20% Must Have (Minimum Requirements): • Bachelor’s degree and a minimum of 4 years of regulatory affairs experience in medical device, or advanced degree and a minimum of 2 years of regulatory affairs experience in medical device Nice to Have (Preferred Qualifications): • Advanced degree in a scientific discipline (engineering, physical/biological or health sciences). • Experience in the preparation of 510(k) or PMA submissions for FDA and Technical Files for EU. • Knowledge of FDA, EU, MHLW, Canada and TGA requirements • Experience with international standards (ISO, GHTF, ICH). • Experience in medical device acquisition due diligence • Excellent interpersonal skills. • Excellent oral and written communication skills. • Proficient computer skills (email, word-processing and spreadsheet software). • Good presentation skills. • Must be able to handle multiple tasks/projects and manage priorities accordingly. • Must have a high tolerance for ambiguity. • Regulatory Affairs Certification • Strong technical writing skills • Ability to effectively manage multiple projects and priorities • Proven ability to lead and work effectively in cross-functional teams • Strong organization and time management skills About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. Physical Job Requirements The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America) Additional Information - Posting Date: May 25, 2021 - Travel: Yes, < 25 % of the Time
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