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Project Leader, Regulatory Affairs - CMF-0134140128
Description
DePuy Synthes Companies of Johnson & Johnson is recruiting for a Project Leader, Regulatory Affairs - CMF, to be located in West Chester, PA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
DePuy Synthes Craniomaxillofacial (CMF) offers a complete array of neuro, craniomaxillofacial, thoracic and soft tissue implants for skeletal and soft tissue repair and reconstruction.
The Project Leader, Regulatory Affairs – CMF is responsible for preparing U.S. submissions, including, but not limited to 510(k)’s, IDE/IDE Supplements and PMA/PMA Supplements, for a diverse range of bone and tissue repair products. This individual is responsible for engaging regulators, when necessary, in oral and written communications to discuss pending or new submissions, regulatory requirements, etc.
Collaborates with European and other RA partners to develop world-wide regulatory strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products. Partners with cross functional teams by providing independent regulatory guidance and support to product development teams for strategic planning, design and development, and post-market surveillance and compliance activities.
The Project Leader, Regulatory Affairs reviews and analyzes technical protocols, data, and reports generated by Product Development, Operations, Clinical Research, Quality Assurance or other related departments Prepares medical device listings, and obtains and maintains Certificates to Foreign Governments and Certificates for Export. Maintains regulatory records, including the ongoing update of a database with regulatory information, and retaining and filing Regulatory paper documentation. Keeps current in regard to US and Canadian regulations, guidance documents, Federal Register notices, and competitor news, and assists in the development of best practices for Regulatory Affairs processes.
Provides assistance and guidance to junior staff members, as well as provides routine regulatory information to associates and affiliates. Reviews and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
The Project Leader, Regulatory Affairs reviews and provides regulatory authorization related to ongoing product design changes and field action investigations. Provides Regulatory Affairs support during internal and external audits. This individual plans schedules for regulatory deliverables on a project and monitors projects through completion.
Qualifications
A Bachelor’s degree and a minimum of 7 years of experience OR an Advanced degree and a minimum of 5 years of experience is required. Solid knowledge of US FDA regulations and review processes are required. Practical experience in a medical device or pharmaceutical regulatory environment, and a successful track record preparing submissions is required. Experience with Class II medical devices is preferred. Experience with pre-submissions, IDEs, and/or Class III devices (PMA or HDE) would be beneficial. Design Dossiers and Technical Files experience is preferred. Experience interacting with US FDA is required.
Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, succinctly and effectively over the phone and in writing. Experience presenting at FDA meetings is preferred. Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive are required. The ability to work as a member of a team in a timeline-driven environment with limited supervision is required. This individual must be detail-oriented while having the ability to handle multiple ongoing projects/tasks is required.
This position is located in West Chester, PA. Up to approximately 10% travel may be required, including some light international travel.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
Primary Location:North America-United States-Pennsylvania-West Chester
Organization: Depuy Orthopaedics. Inc. (6029)
Job Function: Regulatory Affairs
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Project Leader, Regulatory Affairs - CMF-0134140128
Description
DePuy Synthes Companies of Johnson & Johnson is recruiting for a Project Leader, Regulatory Affairs - CMF, to be located in West Chester, PA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
DePuy Synthes Craniomaxillofacial (CMF) offers a complete array of neuro, craniomaxillofacial, thoracic and soft tissue implants for skeletal and soft tissue repair and reconstruction.
The Project Leader, Regulatory Affairs – CMF is responsible for preparing U.S. submissions, including, but not limited to 510(k)’s, IDE/IDE Supplements and PMA/PMA Supplements, for a diverse range of bone and tissue repair products. This individual is responsible for engaging regulators, when necessary, in oral and written communications to discuss pending or new submissions, regulatory requirements, etc.
Collaborates with European and other RA partners to develop world-wide regulatory strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products. Partners with cross functional teams by providing independent regulatory guidance and support to product development teams for strategic planning, design and development, and post-market surveillance and compliance activities.
The Project Leader, Regulatory Affairs reviews and analyzes technical protocols, data, and reports generated by Product Development, Operations, Clinical Research, Quality Assurance or other related departments Prepares medical device listings, and obtains and maintains Certificates to Foreign Governments and Certificates for Export. Maintains regulatory records, including the ongoing update of a database with regulatory information, and retaining and filing Regulatory paper documentation. Keeps current in regard to US and Canadian regulations, guidance documents, Federal Register notices, and competitor news, and assists in the development of best practices for Regulatory Affairs processes.
Provides assistance and guidance to junior staff members, as well as provides routine regulatory information to associates and affiliates. Reviews and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
The Project Leader, Regulatory Affairs reviews and provides regulatory authorization related to ongoing product design changes and field action investigations. Provides Regulatory Affairs support during internal and external audits. This individual plans schedules for regulatory deliverables on a project and monitors projects through completion.
Qualifications
A Bachelor’s degree and a minimum of 7 years of experience OR an Advanced degree and a minimum of 5 years of experience is required. Solid knowledge of US FDA regulations and review processes are required. Practical experience in a medical device or pharmaceutical regulatory environment, and a successful track record preparing submissions is required. Experience with Class II medical devices is preferred. Experience with pre-submissions, IDEs, and/or Class III devices (PMA or HDE) would be beneficial. Design Dossiers and Technical Files experience is preferred. Experience interacting with US FDA is required.
Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, succinctly and effectively over the phone and in writing. Experience presenting at FDA meetings is preferred. Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive are required. The ability to work as a member of a team in a timeline-driven environment with limited supervision is required. This individual must be detail-oriented while having the ability to handle multiple ongoing projects/tasks is required.
This position is located in West Chester, PA. Up to approximately 10% travel may be required, including some light international travel.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
Primary Location:North America-United States-Pennsylvania-West Chester
Organization: Depuy Orthopaedics. Inc. (6029)
Job Function: Regulatory Affairs
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.