Regulatory Affairs Associate

Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Diresh Krishnan at email address View email address on click.appcast.io can be reached on # View phone number on click.appcast.io.

We have Contract role Regulatory Affairs Associate for client at Sylmar, CA Please let me know if you or any of your friends would be interested in this position.

Position Details:

Regulatory Affairs Associate- Sylmar, CA

Location : Sylmar, CA - 91342

Project Duration : 6 Months of contract

Pay Rate : $43.00 per hour on W2

Responsibilities:
• Responsible for filing necessary regulatory applications and supporting interactions with U.S. and international regulatory authorities for products requiring governmental approval. Authoring and submitting U.S. PMA supplements (30-day Notices, Real-Time Reviews, 180-Day Supplements, Annual Reports), as well as supporting EU MDR Technical Documentation updates, change assessments, and Notified Body submissions.
• Review/approval of engineering study protocols/reports and validation study protocols/reports.
• Review and approval of manufacturing and design changes for Class III implantable medical devices, including assessment of regulatory impact under both FDA and EU MDR requirements.
• Relies on experience and judgment to plan and accomplish assigned goals.
• Performs a variety of tasks with guidance as needed.
• Demonstrates accountability for deliverables and ability to follow through on submissions and regulatory activities.
• moderate degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.

Qualifications:
• Requires a bachelor's degree in a scientific or related discipline and at least 1+ years of direct regulatory experience in the medical device field.
• Recent experience with Class III implantable medical devices preferred.
• Exposure to authoring and/or supporting PMA supplements and familiarity with EU MDR (2017/745) requirements are desirable.
• Working knowledge of FDA PMA guidance documents, 21 CFR regulations, and EU regulatory frameworks.

To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Diresh Krishnan at email address View email address on click.appcast.io can be reached on # View phone number on click.appcast.io.

About generis tek : generis tek is a boutique it/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients' specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.