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Overall purpose of job:
Manages submission of new product applications to the regulatory agencies. Directs and coordinates activities concerned with the submission and approval products to government regulatory agencies. Provides guidance to project team members regarding regulatory compliance issues. Oversees the preparation and maintenance of regulatory submissions and files. Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new products and regulatory support of marketed products and other products. Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters. Consults with management personal to establish strategies and prepare appropriate regulatory filings for the regulatory activities. In general, has responsibility for projects of medium and large scope, such as accountability for regional/global/multi-functional projects.
Essential duties and responsibilities:
Functional and Technical Competencies
86 Leverages deep knowledge of the regulatory environment, including compliance, current and proposed laws, regulations and guidance, to develop and oversee the execution of compliant Regulatory strategies that are aligned with business objectives of the company.
86 Leverages a deep scientific and technical understanding of products (medical devices, biologics or pharmaceuticals).
86 Encourages and leads others to find ways to continuously improve, learn about new scientific, technological and Regulatory developments, develop new capabilities, and learn from past challenges and experience in order to proactively adapt to change and drive innovative thinking.
86 Manages projects within timeline and budget requirements by acquiring and coordinating needed resources.
86 Leverages in-depth knowledge of the sector, organizational vision, Regulatory Affairs function, and cross-functional business partners to make informed business decisions and create and execute business strategies.
86 Leverages knowledge of the healthcare environment and external marketplace.
Leadership Competencies
86 Guides others in defining and prioritizing key decision criteria, considering the benefits and risks of alternatives, Credo, and evaluating immediate and future implications when making business level decisions.
86 Quickly and effectively prioritizes critical Regulatory Affairs goals/ initiatives and manages resources in difficult, complex, or crisis situations.
86 Manages change by creating structure and providing clear direction when facing ambiguity and uncertainty.
86 Understands others’ motivations, needs, and concerns even when they are difficult to discern and applies understanding to establish trust and credibility and influence others.
86 Creates compelling negotiating positions that build support and consensus among key stakeholders. Challenges the positions of others to reach win-win outcomes.
86 Mentors others in using verbal communication that are convincing, engaging, and articulate and translate complex information into key facts and rational arguments that are influential, meaningful, and actionable.
86 Fully engages others by asking incisive and provoking questions, always ensuring mutual understanding, particularly when encountering conflicting opinions.
Job requirements:
86 A minimum of a bachelor’s degree in a scientific/engineering field is required. Graduate degree is preferred
86 8 years Regulatory Affairs or related field, Medical Device experience
86 Cardiovascular device experience preferred
86 Experience in dealing with active, implantable product registration, registration maintenance preferred
86 Experienced in developing team and leading team project
86 Excellent communication and strong interpersonal skills
86 Ability to collaborate with cross-functional partners/teams
86 Strong project management skills
86 Well defined problem solving
86 Strong sensitivity for dynamic and multi-cultural environments
86 Experienced in driving industry projects as a lead
86 Experience with international regulations
86 Proven analytical abilities
86 Fluent in both verbal and written English
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