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Regulatory Affairs Manager

Company: Belcan
Location: Richardson
Posted on: January 17, 2020

Job Description:

A Regulatory Affairs Manager job in Richardson, Texas is currently available through Belcan. This is a Direct/Full-time role with one of our medical device clients. You will be responsible for global product and operational compliance related to Class-2 (and accessory) medical device design, manufacture and sales; obtaining regulatory approvals; and establishing and maintaining quality and environmental management systems in keeping with business objectives. To be considered for this role, you will need to have a Bachelor's Degree in a technical discipline and 7-10 years of medical device Regulatory Affairs experience required.

Regulatory Affairs Manager Job duties:
* Get and manage all necessary domestic and international 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.
* Managing the Corrective and Preventive Action (CAPA) system.
* Identify, manage and obtain relevant external standards and ensure changes to standards and new standards introduced are understood and integrated into device design.
* Partake in product development activities, including evaluating and advising personnel on regulatory impact through product lifecycle stages, ensuring that regulatory standards are understood, that a design control system is in place, that design validation activities are conducted, and that a Design History File (DHF) is maintained to support regulatory submissions.
* Take part in the transfer of approved product design to Manufacturing to meet market introduction and other key milestone target dates, ensuring that a Device Master Record is in place (specifications, bill of materials, drawings, material specifications, labeling, etc.).
* Participate in the development of manufacturing and inspection/ test procedures, including required validations for final product release.
* Participate in risk management activities and in the development of risk files for company products to ensure compliance with standards and that output is incorporated into product design.
* Participate in change control activities, such as design changes, manufacturing improvements, new supplier introductions, cost reduction initiatives, etc., ensuring that regulatory standards are understood.
* Manage assigned staff in the day-today performance of their jobs and consultants. Complete performance appraisals and identify and cultivate opportunities for their growth and development.
* Provide mentorship to employees and/or Regulatory Affairs staff, as appropriate.
* Support business relationships by providing regulatory expertise specific to contract manufacturing, private label arrangements, due diligence for possible acquisitions, etc.
* Provide company-wide training and regulatory expertise in Quality Management System (QMS)and Environmental Management System (EMS), as needed.
* Backing Lean and Kaizen initiatives to introduce improvements throughout the quality management system.
* Support Operations reporting and trending

Keywords: Belcan, Dallas , Regulatory Affairs Manager, Executive , Richardson, Texas

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