Regulatory Affairs Analyst

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 www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

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

"I'm looking for a team player who is nimble and familiar with the fast-paced 510K product environment. If you want to jump start your path to a successful career and contribute to keeping patients safe and healthy, I would be very interested in receiving your resume. Let's discuss what you can bring to the team and what you aspire to do in the future "

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

• Assist in the development and deployment of the regulatory program that ensures aggressive product approval, adoption within the international standard ISO13485; 21 CFR 803, 806, and 820; the current Canadian Medical Device Regulations (SOR 980282); Medical Device Directive 93/42/EEC (and all applicable amendments); MHLW Ordinance No 169 and other applicable regulations and guidelines in accordance with corporate objectives.
• Prepare regulatory submission documents for new products or changes to existing health authorities' filings.
• Prepare new product notifications, CE Mark Technical Files/Dossiers, Investigational Device Exemptions and international regulatory submissions in various countries.
• Partner with various teams throughout organization (Marketing, Promotions, Operations, R&D, Quality, etc.) on projects.
• Assist with the management and execution process for global registrations and product life cycle management including generate product catalog and localization of labeling.
• Mentoring junior team members.
• Perform other related duties as assigned.

#LI-PD1

Qualifications

You Bring

• BS or BA degree required, 1-2 years of experience in regulatory affairs.
• Experience working in a medical device manufacturing company, preferably capital medical equipment manufacturer, preferred.
• Knowledge of FDA and ISO regulations/standards.
• Ability to focus on and achieve scheduled milestones.
• Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.
• Competent using office software including MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
• The ability to travel, up to 10%.
• Responsible for performing all duties in compliance with FDA's Quality System Regulation (QSR), ISO13485, MDD, and all other international regulatory requirements with which AbbVie complies.

In this role, we're looking for a leader who will:

• Act as an Owner
• Be Excellence Focused
• Act as an Influencer

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.