Minnnesota Bioscience Jobs

Job Information

Smiths Medical ASD Inc Senior Principal Regulatory Affairs Specialist in Minneapolis, Minnesota

Senior Principal Regulatory Affairs Specialist Location: North America, USA, Minneapolis Ref: MEDNA01082 Division: Medical Job Function: Reg Affairs Quality Assurance Job Description Smiths Medical is currently hiring aSenior Principal Regulatory Affairs Specialistin Minneapolis, MN. TheSenior Principal Regulatory Affairs Specialistwill perform advanced regulatory work requiring recognized expertise in all aspects of regulation, guidance, standards and compliance expectations. This position will be responsible for exploring and recommending innovative, creative and complex technology for use in Smiths Medical product development and market authorization support. This position will also apply advanced theories, concepts, principles, and processes in assigned area of responsibility, while revising new approaches to non-routine problems as encountered. Smiths Medical has a positive impact on someone's life around the world every minute of every day. In fact, over 240 people every minute benefit from a Smiths Medical product. Join us and grow your career while being a part of our continued success! We offer a fun, fast-paced, inspiring and collaborative work environment with opportunities to learn and contribute at all career levels. Innovation is part of who we are, with industry-leading products across a broad spectrum of medical device categories and a strong new product development pipeline. Duties and Responsibilities Provides technical leadership on major programs and provides guidance and direction to the regulatory team. Sets goals/deadlines and adhering to them, holding teams accountable for meeting deadlines to drive results. Develops and conducts Smiths Medical facilitated training and development programs for internal departments designed to increase knowledge in issues related to regulatory. Provides innovative approaches to problem resolution. Represents Smiths Medical, Inc. with customer groups and technical forums such as MDMA and MedTech Europe. No direct subordinates; provides functional supervision to the regulatory team and acts as a recognized leader and authority in the regulatory area. Provides strategic leadership, technical advice and direction to other members of the regulatory team. Drives the decision-making process, conducts meetings, and makes presentations for assigned projects. Oversees the preparation of documentation associated with regulatory submissions including 510(k)s, annual reports, Technical Files and Design Dossiers. Responsible for ensuring the right frequency of communications within and outside of department in support of regulatory activities, such as project management meetings, project review, etc. Establishes and maintain relationships with key individuals and contributors within the regulatory governing community and specifically within agencies in markets we participate in. Work requires the expert application of advanced and innovative regulatory strategies for support of global market authorizations. Oversees regulatory submission strategy development and activities of major significance, which are highly difficult and complex in nature. Plans and assigns work to the regulatory team (tasks and responsibilities; assists in the evaluation of personnel performance. This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site). Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement. Diversity and Inclusion The Individual Scien