Regulatory Compliance Specialist
Company: Quest Medical, Inc.
Location: Allen
Posted on: February 23, 2021
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Job Description:
Summary: The Regulatory Compliance Specialist provides support
to the regulatory team to ensure compliance with applicable
regulations and to support RA initiatives (see below). This
position requires an understanding of medical device regulations
and fulfills the duties and responsibilities described below with
guidance and direction from the Regulatory Affairs Supervisor.
Initiatives: * NPD projects (regulatory assessments, design
reviews, ECO reviews, PPQ reviews, labeling revisions) *
International device registrations (Design Dossier compilation, CFG
requests, document legalization) * Regulatory gap assessments * EU
MDR compliance projects (Technical Documentation, SOP updates,
CERs, PSURs, SCCP, EUDAMED submissions, etc.) * Significant change
submissions (EU, Canada, US) Requirements: * Bachelor of Science
degree in a relevant discipline required. * Minimum two years of
experience in medical device Regulatory Affairs. * Demonstrated
knowledge of FDA QSR, ISO 13485, MDD, MDR, Health Canada, and other
applicable U.S. and International regulations, including experience
auditing these requirements. * Knowledge of Japanese, Australian,
and Brazilian requirements preferred. * Demonstrated knowledge of
ISO 14971 and IEC 60601 preferred. * Experience with preparing and
filing reportable events (MDRs) and Vigilance Reports. * Previous
experience with FDA regulatory submissions and CE marking (510Ks,
EU Technical File etc.). * Experience with the UL certification
process preferred. * Excellent prioritizing, organizational, and
interpersonal skills. Ability to handle multiple projects
simultaneously. * Must possess technical writing, project
management and fundamental problem-solving skills. * Ability to
review and provide critical feedback on design documentation. *
Excellent writing and communication skills. The individual should
be detail-oriented and have good deductive and problem solving
skills. Due to the requirements of a quality assurance environment,
a certain degree of initiative and good mechanical aptitude would
be advantageous. * RAPS RAC (US) preferred. * ASQ certification as
a Certified Quality Auditor (CQA) preferred. Duties: * Prepares
regulatory strategies and maintains submissions for U.S. and
International markets, including but not limited to 510(k)s and
Technical Files, to ensure timely approval of devices and continued
regulatory support of marketed devices. * Reviews and summarizes
post-market surveillance feedback, such as customer feedback,
adverse event reporting, customer surveys, trade shows, and
publications. * Evaluates and documents all alleged reportable
events and field action reviews/assessments. Prepares and submits
all MDRs and associated documentation to the FDA and adverse event
reports to other countries within the required timeframes.
Follows-up, as required, for failure investigations associated with
reportable events. Interacts with the FDA and other regulatory
authorities on all MDR or reportable events. * Maintains and
prepares device registrations, listings, certifications, export
certificates, and Declarations of Conformity. * Responsible for
understanding and complying with current domestic and international
regulatory requirements, including but not limited to FDA,
European, Canadian, Australian, Japanese, and Brazilian
requirements. * Acts as a Regulatory Affairs representative on core
product development teams. Communicates regulatory requirements and
impact of regulations to the development teams. Reviews design
history files to ensure all regulatory requirements are being met.
* Reviews and provides regulatory authorization for labeling,
marketing literature, and protocols/ reports for compliance with
regulatory requirements. * Evaluates, investigates, documents and
communicates with both the FDA and/or other regulatory authorities
on all product recalls. Writes all recall communications to the
field and customers. Documents and reconciles product inventory
associated with recall. Follows up with corrective action
associated with recall issue. * Provides oversight of third party
testing (UL, EMC, biocompatibility, sterilization assurance) as
required. * Supports an effective internal audit program. Reviews
processes for compliance to appropriate regulations and internal
procedures. * Provides support for external audits conducted by
Quest customers, regulatory authorities, and Notified Bodies. An
Equal Opportunity Employer
Keywords: Quest Medical, Inc., Allen , Regulatory Compliance Specialist, Other , Allen, Texas
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