Johnson & Johnson Medical Devices, a member of Johnson
& Johnson family of companies, is currently recruiting for a Project Leader, Regulatory Affairs,
located in Warsaw, IN.
Johnson & Johnson Medical Devices is currently $20
billion in World Wide sales. The business is expected to experience solid
growth over the next 5 to 7 years. Johnson & Johnson Medical Devices
contains key surgical platforms such as Wound Closure, Orthopedics, Open and
Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and
Cardiovascular surgical products.
- Under little or no supervision, responsible for
independently preparing and submitting regulatory submissions for the U.S.,
including 510(k)s, PMAs, PMA Supplements, coordinating IDE submissions, and
interacting with regulatory agencies regarding submissions.
- Responsible for preparing original STEDs, EU
technical files, design dossiers, and technical file revisions for the Global
- Obtains approval of new products and provides
regulatory requirements to help ensure efficient use of product resources.
- Reviews labeling to ensure compliance with
- Provides product information and regulatory guidance
and support to project core teams including processing ECOs, providing guidance
and review of promotional materials, and communicating regulatory
- Serves as a consultant and technical expert on
Regulatory Affairs matters.
- Provides assistance in preparation and
submission of global regulatory documents
- A minimum of a Bachelor’s degree is required,
preferably in a biological/life sciences or engineering discipline.
- 6+ years of Regulatory Affairs experience in a
regulated healthcare environment or industry; or minimum 4 years with advanced
technical degree is require.
- Experience with US FDA Regulations and European
Medical Device Directives required.
- Experience in worldwide regulatory systems
- Demonstrated expertise in medical device
regulatory requirements and processes required.
- Demonstrated expertise in orthopaedics and
orthopaedic device regulatory requirements preferred.
- Outstanding project management skills by
demonstrated competence in managing multiple projects simultaneously required.
BE VITAL in your career; Be seen for the talent you bring to your work.
Explore opportunities within the Johnson & Johnson Family of Companies.
Depuy Orthopaedics. Inc. (6029)Job Function
Regulatory AffairsRequisition ID