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| Associate Director Regulatory MN Open (J#45558) Title: Associate Director Regulatory Company: Hudson Job Description Responsibilities: - Establish and manages systems for assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process. - Prepare and submit product submissions, registrations and dossiers which are clear and concise facilitating easy review and resulting in products being registered or approved in a timely fashion. - Create, review and approve labeling. - Establish relationships with international regulatory agencies and communicate with them as necessary. - Responsible for oversight and prioritization of departmental projects. - Direct and oversee the work of regulatory professionals, including training, mentoring and insuring professional development. Requirements: - Knowledge of international medical device regulations and ability to interpret them. - Ability to lead a team, influence others and handle increasing levels of responsibility. - Ability to build relationships with other areas of the organization. - Bachelor's Degree in Science or technical area. Advanced degree preferred. - Minimum 8 years of previous regulatory experience within the medical device industry. - 15% travel. More... | |||
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