AbbVie

Associate Director, Regulatory Affairs

Employer
AbbVie
Location
Irvine, CA, United States
Posted
Nov 10, 2020
Ref
203652
Required Education
Bachelors Degree
Position Type
Full time
Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.

What Your New Manager Wants You To Know

The Associate Director of 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. 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 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 his/her responsibilities in compliance with all relevant laws, regulations and regulatory guidance as well as all AbbVie policies and procedures.

YOU ARE more than just a title, YOU ARE...

First class team player : collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.

You Will
  • 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 incumbent is the key regulatory contact for International Regulatory Affairs.

#LI-PD1

Qualifications

You Bring
  • 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.
  • 8 years of regulatory experience in the medical device/combination products industry; OR a Master's degree, or JD with a minimum of 6 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.
  • 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 Device/Combination Products.
  • 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 Device/Combination Products.
  • Ability to travel up to 15 % of time

In this role, we're looking for a leader who will :
  • Act as an Owner
  • Be Excellence Focused
  • Act as an Influencer


Job Type
Standard

Schedule
Full-time

Equal Employment Opportunity
At Allergan, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.