Job Information
ManpowerGroup Regulatory Affairs Associate in Los Angeles, California
Our client, a leader in the medical device industry, is seeking a dedicated Regulatory Affairs Associate to join their team. As a Regulatory Affairs Associate, you will be part of the Regulatory Affairs Department supporting the compliance and approval processes for innovative medical products. The ideal candidate will demonstrate strong analytical skills, meticulous attention to detail, and proactive communication abilities, which will align successfully within the organization.
Job Title: Regulatory Affairs Associate
Location: Los Angeles, CA
Pay Range: $45/hr on w2
Application link - https://www.livehire.com/job/abbott/GFJ9P
Share resume - gayatri.samantara@abbott.com
What's the Job?
File necessary applications and manage all government interactions related to product regulation and approval processes.
Author and submit PMA supplements, including 30-day Notices, Real-Time Reviews, 180-Day Supplements, and Annual Reports.
Review and approve engineering study protocols, reports, and validation study documentation.
Review and approve manufacturing changes for Class III implantable medical devices.
Leverage extensive experience and judgment to plan, execute, and lead regulatory projects, potentially guiding and supervising team members.
What's Needed?
Recent experience with Class III implantable medical devices and successful track record of PMA supplement submissions and approvals.
Deep knowledge of FDA PMA guidance documents and CFR regulations.
Possession of an advanced degree relevant to regulatory affairs or medical device engineering, with 5-8 years of direct experience in the field.
Strong analytical skills and the ability to interpret complex regulatory requirements.
Excellent communication skills and the ability to work collaboratively within a multidisciplinary team.
What's in it for me?
Opportunity to contribute to groundbreaking medical device innovations that impact lives.
Engagement in a dynamic and supportive work environment that values expertise and initiative.
Potential for professional growth and development within a leading organization.
Involvement in meaningful projects that advance healthcare technology.
Work in a location that fosters diversity, inclusion, and continuous learning.
Upon completion of waiting period consultants are eligible for:
Medical and Prescription Drug Plans
Dental Plan
Vision Plan
Health Savings Account
Health Flexible Spending Account
Dependent Care Flexible Spending Account
Supplemental Life Insurance
Short Term and Long Term Disability Insurance
Business Travel Insurance
401(k), Plus Match
Weekly Pay
If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells.
ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.
ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.