Title: Regulatory Affairs Manager
Location: King of Prussia, PA
About Camber Spine:
Camber Spine is a fast growing, privately held medical device
company focused on development, manufacturing, and distribution of
state-of-the-art spine technology. We are a market leader with our
3D processing product platforms of Spira and Enza product lines. We
are building a world-class organization based on teamwork, a passion
to move the industry forward and strong work ethic. In a short time,
we have built a cohesive team of talented individuals by creating a
culture of trust combined with a unified vision to improve patient
outcomes through the creation of best-in-class surgeon inspired
spine products. Camber Spine is growing sales at double digit rates
and with passing time is attracting increased attention from growth
capital investors as the Company readies for an initial public
offering. The Company’s fast growth and financial metrics make for
an attractive equity story for investors. We are currently seeking
talented individuals to become part of our fast-growing team. Camber
Spine Technologies is a high energy, team-oriented environment that
cultivates a culture of curiosity, creativity and innovation. Camber
Spine Technologies enjoys a diverse and inclusive work environment
and is an equal opportunity employer.
The Regulatory Affairs Manager will plan, coordinate, and manage
the regulatory activities associated with orthopedic devices to
ensure compliance to internal and external/global requirements
(e.g., FDA, MDSAP, and EU MDR). This person will be responsible for
writing, submitted, and gaining product clearance/approvals for US
and OUS markets. This individual will manage the effective oversight
of regulatory affairs, as well as participate as an active member on
project teams. This is a newly created position which reports to the
Director of Quality.
Job Details, include, but are not limited to:
Develops and implements regulatory strategies for new and
modified products and regulatory processes.
Provides regulatory guidance and direction, in a leadership
role to the organization and acts as a core team member on
development teams and coordinates cross functional deliverables
needed for regulatory submissions.
Prepares submissions (e.g., 510(k)s) to obtain/maintain global
regulatory approvals of products.
Reviews and approves product labeling, advertising, and
promotional materials to assure claims and global regulations are met.
Assist in regulatory pathway determinations and maintain documentation.
Review and file Note-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.
Provides support for internal and external regulatory agency audits.
Maintaining FDA registries, such as GUDID, product
Assist in the preparation of FDA reports and or other documentation.
Assures SOP’s for Regulatory Submissions are current and
compliant with global regulations.
Train new staff on relevant regulatory processes as necessary.
Ensure compliance with applicable governmental laws, rules,
and regulations, both in the United States and internationally, by
completing introductory and annual training and maintaining
knowledge of compliance as it applies to your role.
Applies sound, systematic problem-solving methodologies in
identifying, prioritizing, communicating, and resolving regulatory issues.
Other duties as assigned