Regulatory Affairs Director
Posted on Apr 5, 2021 by Pharmacyclics
The Director of Regulatory Affairs -Emerging Technologies and Combination Products supports regulatory objectives for the company's development and marketed Software Devices and combination products including coordination, management of global submissions and CE technical files/design dossiers. Directs and supports submission activities for a variety of device regulatory approvals including CE mark, US PMAs, US IDEs, US 510(k), post-approval reports, annual reports, export certificates, establishment registrations and device listings. Supports the development of the device regulatory strategy and provides device input into the preparation and maintenance of chemistry, manufacturing and controls (CMC) device sections of regulatory submissions, responses to Agency questions for worldwide registration and lifecycle management for the assigned medical device or device aspect of combination products. Supports regulatory intelligence and policy activities in monitoring regulatory pathways, legislation updates, policies and initiatives that could impact initial product submissions, marketed products. Support Allergan at Regulatory Authority/Notified Body project-specific meetings as well as industry meetings. Provide regulatory support, project management and leadership for the (Medical Device Regulation - MDR and IVDR) implementation globally. Supports due diligence activities and Agency audits/inspections as needed. The employee must carry out his/her responsibilities in compliance with all relevant laws, regulations and regulatory guidance as well as all policies and procedures.
- Leads and/or supports device/combo product development and global filing activities from a regulatory standpoint from initial product concept through life cycle management of the Software Devices and/or Digital Health and Combination Products
- Supports 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.
- Provides regulatory policy, intelligence interpretation and strategy (eg Medical Device Regulation) for device/combination products to support global regulatory plans, due diligence, integrations and divestitures.
- Acts as a key regulatory advisor to provide strategy and leadership by partnering with operating units on the implementation and training of regulatory requirements. Cultivates meaningful and credible partnerships with external subject matter experts, Notified Bodies and regulatory agencies in the development of regulatory policies and assessments. Participates 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.
- Provides leadership, remains accessible and coaches employees when needed; maintains high levels of work and employee accountability
- Supports and develops global regulatory teams to meet company objectives. In addition, the incumbent is the key regulatory contact for International Regulatory Affairs
- Bachelors degree in scientific discipline is required. A Master's degree in a scientific discipline or regulatory and/or law discipline or J.D. is highly desirable.
- 12 years of regulatory experience in the Software Devices and/or Digital Health and Combination Products industry; OR a Master's degree, or JD with a minimum of 8years 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.
- Proven experience in and ability to manage relationships with regulatory agency personnel at all levels.
- Strong knowledge of global regulatory intelligence and policy to analyze external regulatory trends and internal compliance trends, making recommendations to senior management to drive proactive initiatives to ensure compliance for Software Devices and/or Digital Health and Combination Products.
- 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 Allergan's devices and combination products.
- Ability to travel up to  % of time.