Regulatory Affairs Specialist

Nesco Resource•Melville, NY

About The Position

A well-established domestic and international medical device manufacturer is hiring a Regulatory Affairs Specialist with FDA experience. The role reports directly to the Regulatory Affairs Manager and supports regulatory compliance, quality management systems, product registrations, submissions, audits, and new product development. The specialist works with internal cross-functional teams, the parent company, international dealers, and regulatory bodies to maintain compliance with applicable requirements, including FDA, Health Canada, European, Japanese, ISO, and other standards.

Requirements

3–5 years of experience in Regulatory Affairs, Quality Assurance, or Quality Systems within an FDA-regulated industry.
Working knowledge of GMP principles.
Working knowledge of 21 CFR 820, ISO 13485, CMDR, and European Council Directive.
A four-year college degree or practical experience in Regulatory Affairs or Quality Assurance.
FDA experience.

Responsibilities

Prepare and review documentation for internal product registration submissions, including interpreting and preparing additional information requested by international governments.
Maintain FDA establishment registration and device listings, including annual laser product reporting.
Maintain Health Canada establishment registration and device listings, including annual reporting.
Participate in FDA inspections and ISO audits.
Maintain knowledge of and ensure compliance with government and industry regulatory requirements.
Interpret and communicate regulatory changes and their impact on current processes.
Maintain product files and product safety test reports to support regulatory compliance, including UL file maintenance.
Maintain current external regulations and standards and monitor regulatory environments, including ISO, Health Canada, EU, and JPAL requirements.
Maintain domestic product registration and submissions for the City of Los Angeles.
Prepare, maintain, and submit technical files for CE registration.
Communicate 510(k) submission requirements to cross-functional teams and support process improvement activities that assure regulatory compliance, including GMP principles and SOPs.
Oversee day-to-day company QMS activities related to compliance, documentation preparation, and policy deployment.
Review promotional materials and labeling for regulatory compliance.
Write SOPs, work instructions, and forms to support the QMS and regulatory compliance, and recommend updates when regulations or standards change.
Communicate significant issues or developments identified during quality activities and provide management with process improvement recommendations.
Host UL FUS and third-party audits, including audits by Truesdail, NSF, Intertek, and IAPMO.
Support new product development and design changes by advising on regulatory, exporting, labeling, and compliance requirements.
Maintain a list of approved international dealers and authorized, registered products, including expiration dates.
Provide the parent company with regulatory guidance and support on US FDA and Health Canada regulations.
Conduct internal QMS audits, including audits of product and production processes.
Prepare and conduct regulatory affairs training for personnel.
Prepare and report quality metrics.
Perform other duties as assigned.