AbbVie

Sr Regulatory Affairs Analyst - Med Device- Coolsculpting

Employer
AbbVie
Location
Pleasanton, CA, United States
Posted
Sep 19, 2020
Ref
203364
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 www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description

Envision working with energetic colleagues and inspirational leaders. AbbVie is always striving to find top scientists to work at our Pleasanton, CA site. Be Bold and grow your manufacturing biopharmaceutical career with the pharmaceutical and medical device industry leader!

Senior Regulatory Affairs Analyst - Pleasanton, CA

What your manager wants you to know:

"I'm looking for a team player with regulatory affairs experience in medical device (capital equipment) industry. It's going to be a job that always offers new learnings and opportunities of interaction with multiple stake holders. If you're inspired to change the status quo and to drive the project, 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... the liaison between Global CoolSculpting Regulatory Affairs/R&D and international Regulatory Affiliates, actively contributing to the development and implementation of global regulatory strategies throughout the lifecycle of CoolSculpting and body contouring devices.

YOU WILL:

Be a trusted and expert partner. You will be responsible for implementing international solutions for regulatory approvals of products . You will provide technical guidance and product training to international affiliates RA during strategy formulation, submission preparation and development of labeling.

Build bridges globally and cross-functionally. You will apply advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of maintenance changes . You will act as a liaison between international affiliates RA team and CoolSculpting Regulatory, Quality, R&D, Clinical and Operations for major initiatives.

Detailed quality master. You will prepare supporting data package for new devices and maintenance changes . You will review product and manufacturing changes for compliance with applicable regulations (Change Control) . You will review protocols and reports to support regulatory compliance and submissions.

Qualifications

YOU BRING:
  • Bachelor's degree (technical discipline preferred)
  • Minimum 4 years medical device regulatory experience, capital equipment experience is preferred; or minimum 8 years medical device/healthcare industry experience;
  • Sound basis of Scientific (Training/Communications) knowledge
  • Experience in working on regulatory filings and maintenance changes in international markets
  • Prepare & manage filings, ensure thoroughness, accuracy and timeliness of submission filings


ABBVIE LEADERSHIP SKILLS:
  • Excellence Focused
  • Boundaryless Mindset
  • Open and Authentic
  • Strategic Foresight


PDN2

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.