Regulatory Affairs Manager
Posted on: January 17, 2020
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,
* 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
* 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
* 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
* 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
* 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,
* 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),
* 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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