Job Title: Manager Quality Assurance/Regulatory Affairs
Reports Directly To: Director Quality
The Manager of Quality Assurance/Regulatory Affairs has over
responsibility to plan, coordinate, and manage quality/regulatory
activities associated with orthopedic medical devices to ensure
compliance with internal and applicable external requirements (i.e.,
USA FDA). The QA/RA manager has overall responsibility for managing
and collaborating with Engineering and associated personnel to
ensure that product submissions are compiled, submitted, for FDA
product clearance/approvals. This individual will manage the
effective oversight of regulatory affairs, as well as participate as
an active member on project teams. This role includes development,
implementation, maintenance, management of all quality activities,
and continual improvement of the CST Quality Management System.
Job Details, include, but are not limited to:
Serve as the CST Management Representative. Manage and oversee
all aspects of the Camber Spine Technologies (CST) quality
management system, quality assurance activities, and regulatory
activities including but not limited to:
Establish and foster a compliant environment in alignment with
applicable, current regulatory/quality regulations and requirements.
Foster thorough knowledge of quality principles and compliance
with quality policies throughout the organization through training
Maintain overall responsibility for CSTs QMS including but not
limited to, CSTs Quality Manual, document control, design control,
complaints, NCRs, CAPAs, and training.
Compile and conduct annual Management Review meetings
Conduct annual Supplier Review meetings.
Review and approve all internal and external Change Orders.
Serves as CSTs Management Representative, representing CST in
all regulatory and quality interactions with external regulators
such as the US FDA
Develops and implements regulatory strategies for new and
modified products and regulatory processes.
Provides regulatory guidance and direction, to the
organization and acts as a core team member on product development
teams and coordinates cross functional deliverables required for
Ensures submissions are prepared and submitted (e.g., 510(k)s)
to obtain/maintain FDA regulatory approvals.
Reviews and approves product labeling, advertising, and
promotional materials to ensure claims and global regulations are met.
Overall responsibility for regulatory pathway determinations
and maintain documentation.
Collaborate with product development to author Letters-to-File
documentation for design changes to 510(k) cleared products or systems.
Maintains current knowledge of the applicable regulations and
standards and provides guidance to the organization.
Ensures that FDA registries, such as GUDID, product
registrations, and establishment registrations are maintained.
Ensures that SOP’s relative to Regulatory Submissions are
current and compliant with current regulations and standards.
Train new personnel on relevant regulatory processes as required.
Ensures compliance with applicable governmental laws, rules,
regulations, and guidance documents, applicable the United States
and as applicable internationally, by completing introductory and
annual training and maintaining knowledge of compliance.