Regulatory Affairs Associate Jobs

Hello,
This is Subhash from Intellectt.INC, please find the below opening with one of our clients in the USA and try to share your word format resume to [email protected] or call 732 696 7097.
Role: Regulatory Affairs Associate
Location: Santa Clara, CA.
North Chicago, IL
Boston, MA
Columbus, OH

• Review and approval of manufacturing changes for Class III implantable 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).
• Knowledge of FDA PMA guidance documents and CFR regulations.
• Review/approval of engineering study protocols/reports and validation study protocols/reports.
• Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements;
• May require an advanced degree and 5-8 years of direct experience in the field.

Note
Identical requirements as

• Driving implementation of new international regulatory requirements, ensuring procedures are current and regulatory requirements and guidelines are met.
• Fulfilling international submission deliverables for product registration renewals and for regulatory emerging issues where multiple medical devices require submission.
• This role will provide quality, compliance and regulatory support to the Regulatory Affairs organization by
• Monitoring changing regulations (emerging regulatory issues, trends) in rest of the world geographies and translating regulatory requirements into the quality system.
• Driving quality system process improvement initiatives.