Regulatory Affairs Associate

Regulatory Affairs Associate at Experis summary:

Regulatory Affairs Associate for a Fortune 500 medical device company supporting US, EU, and OUS regulatory submissions, with emphasis on Class III implantable devices and PMA supplements. Responsibilities include authoring and submitting PMA supplements and reports, reviewing/approving engineering and validation study protocols, and managing regulatory impact assessments and manufacturing changes. Role requires 3–8 years' regulatory affairs experience (preferably 5–8 with advanced degree), strong FDA CFR and PMA guidance knowledge, and onsite work in Temecula, CA without sponsorship.

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.

Top Skills:

• 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

Job Responsibilities:

• 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

Education:

• 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

Keywords:

medical device regulatory, PMA supplements, Class III implantable, FDA CFR, regulatory submissions, technical documentation, change management, international registrations, validation protocols