About the Role We are seeking a skilled Regulatory Affairs Professional to join our team. As a key member of our organization, you will play a critical role in ensuring compliance with regulatory requirements for medical devices. This position requires strong knowledge of regulations pertinent to medical devices, biologics, drugs and combination products. You will be responsible for assisting with regulatory filings, preparing and submitting product registrations, renewals and registration changes. You will also be involved in maintaining registration databases, product registration records and communicating approved registrations to stakeholders. In addition, you will provide regulatory direction to development project teams, develop regulatory strategies for new products and evaluate risk associated with proposed regulatory strategies. Responsibilities - Preparation, assembly, storage, tracking and retrieval of information pertinent to the regulatory processes, including the regulatory submissions process. - Authoring and publishing electronic submissions for product registrations, renewals and registration changes. - Maintaining registration databases, product registration records, key performance indicators current, and communicating approved registrations. - Executing registration processes in assigned countries, working closely with Business Unit Regulatory Teams to request information, business partners to ensure registrations are submitted on time and kept current in compliance with applicable legislation. - Providing regulatory direction to development project teams as a core team member; developing regulatory strategy for new products. - Evaluating risk of proposed regulatory strategies; may offer solutions. - Reviewing proposed labeling and package inserts for compliance with applicable regional regulations. - Responding to requests for additional information from foreign governments. - Reviewing proposed product changes for impact on regulatory status of the product. - Supporting the creation of Technical documentation files in the Regulatory Information Management System. - Applying regulations to business practices and providing regulatory input, advice and guidance to cross-functional teams. Requirements - Strong writing, communication, and interpersonal skills. - Strong attention to detail; ability to multi-task and balance competing priorities. - Knowledge of overall business environment, the orthopedic industry, and the marketplace. - Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional area. - Ability to building relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels. - - Ability to identify risk in Regulatory strategies. - Strong problem solving skills. - Effective negotiating skills. - Basic computer skills, including Microsoft Office Suite. Education and Experience - Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred. - English Proficiency is required. - A minimum of one year of experience in orthopedic or medical device industry preferred. - A minimum of 3-5 years of experience in Regulatory Affairs, Engineering, Quality, or related field required. - Regulatory Affairs Certification (US, EU, or Global) preferred. - A combination of education and experience may be considered. Travel Expectations Up to 10% ],