Sr. Manager Regulatory & Clinical Affairs - (US-MA-South Attleboro - 02703)

Minimum Education: None
Jobcode: L:105230076
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Responsibilities:




Recruit, manage, develop and mentor regulatory affairs professionals. Work with regulatory associates, determine submission and approval requirements and prepare regulatory submissions. Monitor and submit applicable reports and responses to regulatory authorities and negotiate and interact with regulatory authorities during the development and review process to ensure submission clearance or approval. Assist in regulatory due diligence and acquisition transfer activities. Prepare and manage annual budgets. Manage and execute pre-approval compliance activities. Maintain annual licenses, registrations, listings and patent information. Review and approve labeling, advertising and promotional items to ensure compliance with regulations and company policy. Review publicly disseminated information to minimize regulatory exposure, review product claims and preserve confidentiality of applicable product information. Review and approve required reports, supplemental submissions and other post-marketing commitments to update and maintain product approvals and registrations. Provide regulatory input for and appropriate follow-up to inspections and audits. Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events. Submit/review change controls to determine the level of change and consequent submission requirements. Provide training for stakeholders on current and new regulatory requirements to ensure company-wide compliance. Conduct technical meetings with regulatory advisory committees and government agencies.




Qualifications :




B.S. Science, Engineering, Medical, or other technical Degree RAC preferred 5-8 years experience with regulatory submissions for medical devices IDE’s, 510k’s, and PMA’s Familiarity with drug/device combination products preferred Knowledge of medical products quality system principles and practices Ability to work in a matrix/team environment with prior experience supervising regulatory affairs professionals. Some travel required.




Required Qualifications :




Must have demonstrated extensive working knowledge of the U.S.A. Federal Regulations for medical devices including those applicable to the import/export of devices. Must have demonstrated extensive working knowledge with the requirements for medical device registration/licensing in the EU, Medical Device Directive, Japan, Canada, Australia, Latin America and Asia/Pacific.