Regulatory Affairs – Device/Combination products supports regulatory objectives for the company’s development and marketed device/combination products including coordination, management of global submissions and CE technical files/design dossiers. Provide support to 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. Support 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. Support regulatory intelligence and policy activities in monitoring regulatory pathways, legislation updates, policies and initiatives that could impact initial product submissions, marketed products. Support AbbVie 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 their responsibilities in compliance with all relevant laws, regulations , and regulatory guidance as well as all AbbVie policies and procedures.

　　Responsibilities:

　　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, field actions, change control, lifecycle management, interactions with regulatory agencies/Notified Bodies, technical file/design dossier management.

　　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.

　　Cultivate 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.

　　Maintain regulatory documentation, procedures, and files, including, but not limited to, device listing and registered/approved product listing. Provides input for global regulatory planning and identification of regulatory gaps or risks within a global strategic plan. Contributes to the development of regulatory strategies.

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　　Qualifications:

　　Bachelor's 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.

　　2-5 years of regulatory experience in the medical device/combination products industry; OR a Master’s degree, or JD with a minimum of 1 year of Regulatory experience in the medical device and combination products industry. Experience working in an international setting highly preferred

　　Knowledge of the ISO/CE process and global product registration process. Experience with eCTD tools and EDMS applications.

　　Background in regulatory affairs, manufacturing, marketing, or quality assurance sufficient to understand how products are produced and marketed.

　　Knowledge of global regulatory intelligence and policy to analyze external regulatory trends and internal compliance trends to drive proactive initiatives to ensure compliance for Device/Combination Products.

　　Understanding of device/combination product regulations [21 CFR Parts 3, 4, GCP, GLP, 210/211, 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.

　　Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

　　The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

　　We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

　　This job is eligible to participate in our short-term incentive programs.

　　Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law .

　　AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.