Codman & Shurtleff, Inc., a
member of Johnson & Johnson's Family of Companies, is currently recruiting
for a Manager, Regulatory Affairs located in
DePuy,
Inc. develops and markets products under the DePuy Orthopaedics, DePuy Spine,
CODMAN® and MITEK® brands. DePuy Orthopaedics and DePuy Trauma and Extremities
provide products for reconstructing damaged or diseased joints, and for
repairing and reconstructing traumatic skeletal injuries. DePuy
Spine facilitates fusion of the spine and correction of spinal deformities,
including CHARITÉ™, the first artificial spinal disc. Codman provides for the
surgical treatment of neurological and central nervous system disorders through
products such as hydrocephalic shunt valve systems, implantable drug pumps and
micro-surgical instrumentation. DePuy Mitek offers innovative devices in sports
medicine for the treatment of soft tissue injuries.
The Manager, Regulatory Affairs
will coordinate the preparation of US and
International regulatory submissions, including, but not limited to 510(k),
IDE, PMA Supplements, Design Dossiers/Change Notifications, and Technical
Files. The ideal candidate will
have the ability to devise strategic
regulatory plans to ensure rapid and timely approval of devices and continued regulatory
support of marketed devices and other products. This position is directly
responsible for the management and development of up to 5 associates.
This position will participate and provide guidance and
support to Codman management board and product development teams. Review and
analyze ECOs, NCRs, special devices, labeling, manufacturing, marketing and
clinical protocol procedures and documents.
Review and analyze technical data generated by Research and Development,
Marketing/Sales, Clinical Research, Quality Assurance or other related
departments. Review, analyze and incorporate into submissions relevant clinical
literature. Respond to requests from
foreign governments and/or distributors to prepare and submit documentation for
marketing approvals in other countries, as well as provide routine regulatory
information to associates and affiliates.
Interact with Regulatory Agencies and direct/expedite submissions
through approval process.
A minimum of a Bachelor’s Degree is required. An Advanced Degree is preferred. Must have a minimum of 8 years experience
working in a Regulatory Affairs role.
Preparing submissions for complex Class II or Class III medical devices
is a plus. Experience with NDA, IND
submission is a plus. A minimum of 2
years direct management experience is required.
Experience in the independent preparation and submission of
510(k)’s, PMA Supplements or IDEs is desired.
Must have proven experience managing complex project teams dealing with
day-to-day issues. Experience in drugs/biologics of complex Class III devices
is preferred (including devices that incorporate software or electronics)
Knowledge of US, European and International regulatory processes is required.
Experience conducting due diligence activities from a Regulatory/business
standpoint is a plus.
Solid interpersonal skills including the ability to remain
calm, professional, diplomatic, and positive is required. Must be able to work in a timeline-driven
environment. Solid word processing
skills with knowledge of Word, Visio, PowerPoint and Microsoft Project is
required.
If you want to explore the many
small-company environments behind the big-company impact of the Johnson &
Johnson Family of Companies, bid on this position today!
As a valued team member, you’ll receive a competitive salary and great benefits including medical/dental, a 401(k), a pension plan and a comprehensive wellness program. If interested, please apply directly on-line at our web site www.jnj.com/careers and email mhannan3@corus.jnj.com noting Req. Code 0803719. The Johnson & Johnson Family of Companies has a strong commitment to diversity and welcomes applications for all individuals. EOE M/F/D/V