Regulatory Affairs Associate
ManpowerGroup Global, Inc., Wind Lake, WI, United States
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
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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
#J-18808-Ljbffr