Regulatory Affairs Associate

Title: Regulatory Affairs Associate
Location: Temecula, CA(100% Onsite)
Duration: 3+Months
Shift Time: 9am to 5pm
Pay Range: $20/hr to $24/hr (On W2)

We are looking for a “Regulatory Affairs Associate” to join one of our Fortune 500 clients.

• Basic knowledge of US and EU medical device regulatory requirements
• Experience supporting OUS/international registrations; experience with change management and regulatory impact assessments
• Experience with technical documentation writing
• 3-4 years regulatory affairs experience with medical devices

• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
• Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
• Review/approval of engineering study protocols/reports and validation study protocols/reports.
• Review and approval of manufacturing changes for Class III implantable medical devices.
• Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements
• Knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals

• May require an advanced degree and 5-8 years of direct experience in the field.
• Recent experience with Class III implantable medical devices
• Performs a variety of tasks. May lead and direct the work of others.
• A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.

We are looking for the candidate who are eligible to work with any employers without sponsorship.

If you’re interested, please click “Apply” button