Sr. Manager, Regulatory Affairs

Irvine, CA, United States
Oct 01, 2020
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description

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 Sr. Manager of Regulatory Affairs - Combination products/Device 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. Serves as AbbVie's back-up person responsible for regulatory compliance (Medical Device Regulation - MDR and IVDR). 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.
  • Be the Back-up Person Responsible for Regulatory Compliance (PRRC) Article 15 of the EU MDR and EU IVDR
    1. the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date
    2. 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



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.
  • 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.
  • 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 Device/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 AbbVie's devices and combination products.
  • The ability to travel 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

Equal Employment Opportunity
At AbbVie, 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.