Regulatory Affairs Vice President (508094) at Zimmer US
Posted in Management 12 days ago.
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Location: Warsaw, Indiana
Directs the organization’s Corporate Regulatory Affairs activities to ensure that global goals in these areas are met. Develops and communicates a vision for the Regulatory functions including the development of a global strategy in the area of regulatory submissions.
Principal Duties and Responsibilities
Develops relationships inside and outside of Zimmer Biomet, with regulatory and government organizations and agencies. Drives regulatory process to ensure timely filing and approval of new products in accordance with business objectives. Acts as a credible, influential, and respected corporate spokesperson for interactions and negotiations with global regulatory and governmental agencies on all regulatory-related matters Anticipates future regulatory changes and impact on business success and takes the action necessary to limit the effect on Zimmer Biomet business. Acts as a consultant to senior management on regulatory issues and is proactive in making the Company aware of impending product or regulatory issues that present a risk to the business. Utilizes available resources to drive the decision-making process involving Regulatory issues. Selects, develops and manages a team of regulatory professionals Sets high standards and holds employees accountable for achievement of stated objectives. Develops emerging talent to assume new or increased responsibilities in the future. Interpretation of FDA (and other major international regulatory body) regulations as they apply to Zimmer Biomet and other appropriate areas of the company.
Expected Areas of Competence
-Ability to foster individual and group development by identifying and arranging appropriate assignments, formal training or other experiences. -Must possess strong knowledge of the regulations and the regulatory process in all global markets. -Strong written and verbal communication skills including the ability to communicate effectively to diverse audiences. -Exhibits good business sense, capable of identifying business needs and opportunities relative to products and services. -Acts in a balanced and ethical manner when dealing in gray areas of regulation. -Strong knowledge of orthopedic products and processes involved in their manufacture -Ability to represent Zimmer Biomet globally to influence regulatory affairs and government legislation in a positive way for the company. -Broad familiarity with medical device operations including first-hand knowledge of the manufacturing and development processes. -Technical knowledge/experience in the medical device industry.
-Must possess a minimum of a Bachelor’s Degree in Biology, Engineering, or other relevant discipline. -RAC preferred. -A minimum of 15 years of experience in a regulatory-related leadership role in a leading medical device organization -Prior experience which required personally working with governmental and regulatory agencies, and establishing relationships with key individuals in those agencies. -Experience with global regulatory submission process. -Previous responsibility for managing a large budget and achieving profit and loss objectives.
Up to 25%