Senior Associate, RA Device/Combination Products (Remote)

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at ~~~. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

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.

Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day),Keyboard use (greater or equal to 50% of the workday)

Qualifications

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.

Additional Information

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.