Regulatory Affairs Manager Job duties:
Get and manage all necessary domestic regulatory registrations, product clearances/ approvals, certifications.
Maintain documentation needed to support FDA, ISO and EU/international compliance, allowing for the sale of Company products in US, EU, Canadian and other international markets
Gather, submit, and monitor reports and responses to regulatory authorities.
Assist with coordinating inspections of Company, its subsidiaries, and contract manufacturers.
Design, implement, and maintain an Internal Audit Program company-wide for a fully compliant Quality Management System (QMS) - including within its scope applicable accreditation and Home Medical Equipment (HME) for Durable Medical Equipment (HME) compliance provisions - and Environmental Management System (EMS). Grow program and provide support as additional sites/ operations are added subject to Company's QMS.
Lead and conduct or support second-party supplier audits, as needed.
Manage post market surveillance (PMS) and vigilance activities, including customer complaints/ adverse medical event reporting systems, clinical reports, etc.
Bachelor's Degree in a technical discipline required and 7-10 years Regulatory Affairs experience
ISO 13485 (current edition) Lead Auditor Certification and/or ASQ CQA and/or ASQ CBA preferred.
Advanced knowledge of ISO 9001 required.
Advanced knowledge of ISO 9000 required.
Knowledge of ISO, MDD/ MDR, and FDA regulations required
Knowledge of DMEPOS accreditation requirements.
Ability to facilitate external/ internal audits required. Required
Attention to detail and process improvement understanding required
DOE - $60-70,000
LOCATION - Plano,Texas