Senior Manager Regulatory Affairs

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Senior Manager, Regulatory Affairs
The candidate will be responsible for: Lead and/or support device/combo product development and global filing activities from a regulatory standpoint from initial product concept through life cycle management of the device/combination product. Support regulatory submissions, regulatory operations, field actions, change control, lifecycle management, interactions with regulatory agencies/Notified Bodies, technical file/design dossier management and approval of EC Declaration of Conformity as applicable, per product type. In addition, the incumbent is the key regulatory contact for Quality, Medical Safety and International Regulatory Affairs. Provide regulatory policy, intelligence interpretation and strategy (e.g. Medical Device Regulation) for device/combination products to support global regulatory plans, due diligence, integrations and divestitures. Act as a key regulatory advisor to provide strategy and leadership by partnering with operating units on the implementation and training of regulatory requirements. Cultivate meaningful and credible partnerships with external subject matter experts, Notified Bodies and regulatory agencies in the development of regulatory policies and assessments. Participate in and contributes to industry and professional meetings to maintain competency on regulatory policy issues. In addition, the incumbent is the key regulatory contact for Quality, Medical Safety, International Regulatory Affairs and external third party regulatory experts. Provide leadership, remains accessible and coach employees when needed; maintains high levels of work and employee accountability. Support and develop global regulatory teams to meet company objectives. In addition, the key regulatory contact for International Regulatory Affairs. Be the Back-up Person Responsible for Regulatory Compliance (PRRC) Article 15 of the EU MDR and EU IVDR the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV [Section 4.1 of Annex XIV of the IVDR] is issued. Must have Bachelor's degree in scientific discipline. A Master’s degree in a scientific discipline or regulatory and/or law discipline or J.D. is highly desirable. Should have 6 years of regulatory experience in the medical device/combination products industry; OR a Master’s degree, or JD with a minimum of 4 years of Regulatory experience in the medical device and combination products industry. Experience in the CE Marking process, global regulatory strategy and regulatory submission process. Sound technical skills including working knowledge of medical device and combination products. Experience with eCTD tools and EDMS applications. Must have proven experience in and ability to manage relationships with regulatory agency personnel at all levels. Should have strong knowledge of device/combination product regulations [21 CFR Parts 3, 4, GCP, GLP, 210/211, 600, 700, 807, 809, 803, 812, 814, 312, 314, 1271, 820 QSR (Design Control), European Medical Device Directives and Regulation (MDR/IVDR), ISO 13485, MDSAP, technical standards, CMDR SOR/98-282, TGA SR. 236:2002, ANVISA RDC No. 16, JPAL Ordinance 169, MFDS No. 219, ISO 14155, eCTD Module 3, ISO/IEC 62366, HE 74, device complaint handling/MDRs, human factors testing, device risk analysis (ISO 14971) and other global regulatory requirements for AbbVie’s devices and combination products.

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